Diabetes clinical trials at UCSF
31 in progress, 15 open to eligible people
A Multiple Ascending Dose Trial Investigating Safety, Tolerability and Pharmacokinetics of NNC0361-0041
open to eligible people ages 18-45
The trial is a placebo-controlled, double-blinded within cohorts, randomized, multiple ascending dose trial with a sequential trial design. The primary outcome is to investigate the safety and tolerability of ascending subcutaneous weekly doses of NNC0361-0041 plasmid in patients with T1D.
San Francisco, California and other locations
Afrezza® INHALE-1 Study in Pediatrics
open to eligible people ages 4-17
INHALE-1 is a Phase 3, open-label, randomized clinical study evaluating the efficacy and safety of Afrezza in combination with a basal insulin (i.e., the Afrezza group) versus insulin aspart, insulin lispro or insulin glulisine in combination with a basal insulin (i.e., the Rapid-acting Insulin Analog [RAA] injection group) in pediatric subjects with type 1 or type 2 diabetes mellitus. Following 26 weeks of randomized treatment (i.e., Afrezza or RAA injection combined with a basal insulin), all subjects will enter a treatment extension where subjects will receive Afrezza until Week 52. The purpose of the treatment extension is to assess safety and efficacy with continued use of Afrezza. Pediatric subjects ≥4 and <18 years of age will be enrolled in this study. Subjects will be randomly assigned in a 1:1 ratio to either the Afrezza group or the RAA injection group. The study is composed of: - Up to 5-week screening/run-in period - 26 week randomized treatment period - 26-week treatment extension - 4-week follow-up period
San Francisco, California and other locations
Changing Health Through Food Support for Diabetes
open to eligible people ages 18 years and up
This is a pragmatic randomized controlled trial (RCT) of Changing Health through Food Support for Diabetes (CHEFS-DM). This pragmatic RCT will leverage Project Open Hand's (POH) real-world programs to test the impact of a six month medically tailored food support and nutrition intervention ("CHEFS-DM") on glycemic control and other cardiometabolic outcomes, investigate the paths through which CHEFS-DM may durably improve health, and assess the economic value of the intervention to society.
San Francisco, California
Extended Bolus for Meals in a Closed-loop System
open to eligible people ages 13-18
This study aims to evaluate whether the use of an extended bolus will improve glucose control with high-fat high protein meals using a closed-loop system. The new knowledge gained from this study may provide a method to allow for the proper administration of insulin over an extended period to mitigate the risk of prolonged hyperglycemia or early hypoglycemia.
San Francisco, California
Fenofibrate for Prevention of DR Worsening
open to eligible people ages 18-80
This randomized trial will evaluate the effect of fenofibrate compared with placebo for prevention of diabetic retinopathy (DR) worsening through 4 years of follow-up in eyes with mild to moderately severe non-proliferative DR (NPDR) and no CI-DME at baseline. In addition to evaluating efficacy, this study aims to evaluate the feasibility of a model for ophthalmologists to prescribe or collaborate with a primary care provider such as an internist/endocrinologist to prescribe and monitor the drug safely. If this study demonstrates that fenofibrate is effective for reducing the onset of proliferative diabetic retinopathy (PDR) or and the results are adopted by the community of retina specialists, a new strategy to prevent vision threatening complications of diabetes could be widely adopted. Widespread use of an oral agent effective at reducing worsening of DR would decrease the numbers of patients who undergo more invasive and much more expensive treatment for DR and who are consequently at risk for side effects that adversely affect visual function. This study will also assess the relationship of glycemic variability, as measured by continuous glucose monitoring with DR outcomes. Ancillary studies will characterize functional and structural outcomes in this cohort.
San Francisco, California and other locations
Pancreatic Islets and Parathyroid Gland Co-transplantation for Treatment of Type 1 Diabetes
open to eligible people ages 18 years and up
The primary objective is to test the hypothesis that co-transplantation of allogeneic PTG with adult pancreatic islets (derived from same deceased donor) in the IM site in people with Type 1 diabetes with functioning kidney and/or liver transplants is safe, allows islet engraftment, and leads to insulin independence.
San Francisco, California
Pilot Trial of the Nutrition-Supported Diabetes Education Program
open to eligible people ages 18 years and up
This is a pragmatic, pilot randomized controlled trial (RCT) of the Nutrition-Supported Diabetes Education Program (NU-DSMP). This study will test the feasibility and preliminary impact of providing diabetes-tailored food support and individualized case-management on glycemic control and other intermediate outcomes including food security, diet, mental health, and health care behaviors, among Medicaid-enrolled patients with type 2 diabetes in a safety-net county health system.
Martinez, California
Safety and Effectiveness of the MiniMed™ 780G System With DS5 CGM
open to eligible people ages 7-80
The purpose of this study is to confirm the safety and effectiveness of the MiniMed 780G insulin pump used in combination with the DS5 CGM in type 1 diabetes adult and pediatric subjects in a home setting.
San Francisco, California and other locations
The Lifestyle Education About Nutrition for Diabetes (Legend) Study
open to eligible people ages 21 years and up
This study is being completed to compare two dietary approaches for participants with type 2 diabetes. This research will test whether a very low-carbohydrate or a plate-method diet better improves outcomes for blood glucose control and body composition for patients with type 2 diabetes that follow one of these approaches for 12 months. Participants that meet screening and eligibility will be randomized to one of the two diets. In addition to the diet, study specific visits and assessments will be performed at various timepoints.
San Francisco, California and other locations
Adjunct Collection of Additional Biorepository Data From Patients Enrolled in Diabetic Foot Consortium (DFC) Trials
open to eligible people ages 18 years and up
The Biorepository will guide the Diabetic Foot Consortium (DFC) activities for collection and storing biosamples and data from participants enrolled in other current and future DFC research studies.
San Francisco, California and other locations
C-myc Biomarker Study for Diabetic Foot Ulcers
open to eligible people ages 18 years and up
This is a multi-center observational cohort study of patients with diabetic foot ulcers (DFU) to develop and validate potential tissue-based biomarkers that predict complete wound healing. Eligible and consented participants will begin standard of care treatment after collection of tissue specimens from the wound's edge. An additional tissue specimen is collected at 4 weeks if clinically indicated. Tissues will be tested for c-myc and phosphorylated glucocorticoid receptor (p-GR) levels using validated protocols at a central laboratory. Participants will be followed weekly for up to 12 weeks or until complete wound healing (whichever occurs first). One final assessment 2 weeks after complete wound healing will occur to confirm healing.
San Francisco, California and other locations
Inflammation, Diabetes, Ethnicity and Obesity Cohort
open to eligible people ages 18-75
Obesity affects over one third of US adults (>72 million, with BMI ≥30 kg/m2), and the proportion of US adults with BMI ≥40 kg/m2 has doubled in the last 20 years. Obesity is associated with increased mortality through its linkage to comorbidities including diabetes, hypertension, dyslipidemia, osteoarthritis, sleep apnea and psychosocial disturbances. Given its prevalence, impact on morbidity and mortality, and economic cost, limiting the spread of obesity and its consequences is one of the most important problems of our time. In this proposed study, investigators will recruit participants from a wide range of body mass index (BMI), ethnicity and Diabetes risk to collect data and blood, stool and adipose tissue samples in the San Francisco bay area.
San Francisco, California
Progression and Etiology of Cortical Porosity in Diabetic Bone Disease
open to eligible people ages 50-70
Type 2 diabetes is associated with increased cortical bone porosity and increased fracture risk. The goal of this proposed study is to understand the longitudinal evolution of cortical bone porosity and to investigate the underlying biological processes that drive increased cortical porosity and fracture risk in the setting of diabetes. The investigators will apply novel techniques for in vivo imaging of cortical pores to patients with type 2 diabetes and controls in a longitudinal prospective study. This work will establish the longitudinal progression of cortical porosity and determine whether pore content can serve as a predictor of future cortical degradation and bone fragility.
San Francisco, California
TrialNet Pathway to Prevention of T1D
open to eligible people ages 30 months to 45 years
Rationale: The accrual of data from the laboratory and from epidemiologic and prevention trials has improved the understanding of the etiology and pathogenesis of type 1 diabetes mellitus (T1DM). Genetic and immunologic factors play a key role in the development of T1DM, and characterization of the early metabolic abnormalities in T1DM is steadily increasing. However, information regarding the natural history of T1DM remains incomplete. The TrialNet Natural History Study of the Development of T1DM (Pathway to Prevention Study) has been designed to clarify this picture, and in so doing, will contribute to the development and implementation of studies aimed at prevention of and early treatment in T1DM. Purpose: TrialNet is an international network dedicated to the study, prevention, and early treatment of type 1 diabetes. TrialNet sites are located throughout the United States, Canada, Finland, United Kingdom, Italy, Germany, Sweden, Australia, and New Zealand. TrialNet is dedicated to testing new approaches to the prevention of and early intervention for type 1 diabetes. The goal of the TrialNet Natural History Study of the Development of Type 1 Diabetes is to enhance our understanding of the demographic, immunologic, and metabolic characteristics of individuals at risk for developing type 1 diabetes. The Natural History Study will screen relatives of people with type 1 diabetes to identify those at risk for developing the disease. Relatives of people with type 1 diabetes have about a 5% percent chance of being positive for the antibodies associated with diabetes. TrialNet will identify adults and children at risk for developing diabetes by testing for the presence of these antibodies in the blood. A positive antibody test is an early indication that damage to insulin-secreting cells may have begun. If this test is positive, additional testing will be offered to determine the likelihood that a person may develop diabetes. Individuals with antibodies will be offered the opportunity for further testing to determine their risk of developing diabetes over the next 5 years and to receive close monitoring for the development of diabetes.
San Francisco, California and other locations
Type 1 Diabetes Extension Study
open to eligible people ages 8-35
This is a multi-center, prospective, non-interventional study that focuses on the long- term effects following participation in selected ITN new-onset Type1 Diabetes Mellitus studies with immunomodulatory agents (T1DM, T1D). This observational study will: - follow participants to determine how long they continue to produce insulin, and - will also assess how changes in the immune system over time relate to the ability to produce insulin. This information could help design better therapies for type 1 diabetes in the future.
San Francisco, California and other locations
Rituximab and Abatacept for Prevention or Reversal of Type 1 Diabetes
Sorry, currently not accepting new patients, but might later
The study is a clinical trial testing sequential therapy with rituximab followed by abatacept in individuals destined to develop clinical type 1 diabetes.
San Francisco, California and other locations
A Multicenter, Randomized Study in Participants With Diabetic Retinopathy Without Center-involved Diabetic Macular Edema To Evaluate the Efficacy, Safety, and Pharmacokinetics of Ranibizumab Delivered Via the Port Delivery System Relative to the Comparator Arm
Sorry, in progress, not accepting new patients
Study GR41675 is a Multicenter, Randomized Study in Participants with Diabetic Retinopathy (DR) Without Center-Involved Diabetic Macular Edema (CI-DME) to Evaluate the Efficacy, Safety of the Port Delivery System with Ranibizumab (PDS) Relative to the Comparator Arm
San Francisco, California and other locations
Behavioral Approaches to Reducing Diabetes Distress and Improving Glycemic Control
Sorry, in progress, not accepting new patients
This study is comparing three programs to reduce Diabetes Distress (the worries and concerns that people with diabetes may experience as they struggle to keep blood glucose levels in range) in adults with type 1 diabetes. About a third of participants will take part in the TunedIn program, about a third will take part in the FixIt program, and about a third in the StreamLine program.
San Francisco, California
COHERE - COntextualized Care in cHcs' Electronic Health REcords
Sorry, accepting new patients by invitation only
This study was designed to develop and test clinical decision support (CDS) tools that present clinical care team members with a given patient's social risk information and recommend care plan adaptations based on those risks. This study will test the hypothesis that providing care team members with CDS about patients' known social risks will result in improved outcomes. This study's focus is on hypertension and diabetes control, but the results will have implications for a wide range of morbidities.
San Francisco, California and other locations
CTLA4-Ig (Abatacept)for Prevention of Abnormal Glucose Tolerance and Diabetes in Relatives At -Risk for Type 1
Sorry, in progress, not accepting new patients
The study is a 2-arm, multicenter, 1:1 randomized, placebo controlled clinical trial. All subjects will receive close monitoring for development of AGT or T1DM. Subjects will receive Abatacept or placebo and close monitoring for development of AGT or T1DM. To assess the safety, efficacy, and mode of action of Abatacept to prevent AGT and T1DM. The primary objective is to determine whether intervention with Abatacept will prevent or delay the development of AGT in at-risk autoantibody positive non-diabetic relatives of patients with T1DM. Secondary outcomes include: the effect of Abatacept on the incidence of T1DM; analyses of C-peptide and other measures from the OGTT; safety and tolerability; and mechanistic outcomes.
San Francisco, California and other locations
Diabetes Autoimmunity Withdrawn In New Onset and In Established Patients
Sorry, in progress, not accepting new patients
The study is a prospective, randomized, 52-week double-blind, placebo-controlled, multicenter trial in subjects with T1D followed by a 2-year safety follow-up.
San Francisco, California and other locations
Diabetes Study of Linagliptin and Empagliflozin in Children and Adolescents (DINAMO)TM
Sorry, in progress, not accepting new patients
The purpose of this research study is to evaluate the efficacy and safety of an empagliflozin dosing regimen and one dose of linagliptin in patients with type 2 diabetes who are aged 10 to below 18 years and are currently taking metformin, insulin or both drugs (DINAMO TM) or who are treatment naïve or not on active treatment after metformin withdrawal (DINAMO TM MONO) . Empagliflozin and linagliptin are both approved for use in adult patients with type 2 diabetes. This study will assess how well empagliflozin and linagliptin work by finding out how these treatments affect blood glucose (sugar) levels compared to placebo (a pill that contains no active drug), in children and adolescents. Empagliflozin and linagliptin are considered investigational products in this study since while they have been approved for use in adults, they have not been approved for children and adolescents due to lack of clinical studies in this specific population. Patients with type 2 diabetes have higher levels of blood glucose (sugar) than patients who do not have this disease. The high level of sugar in the blood can lead to serious short-term and long-term medical problems. The main goal of treating diabetic patients is to lower blood glucose to a normal level. Lowering and controlling blood glucose help prevent or delay complications of diabetes such as heart disease, kidney, eye and nerve diseases, and the possibility of amputation. Empagliflozin is a drug that helps to reduce blood glucose (sugar) levels by causing glucose to be excreted in the urines. Linagliptin works by increasing the production of insulin (a hormone that controls the level of blood glucose) after meals when blood glucose (sugar) levels are too high. This helps to lower blood sugar levels. The subject will either receive one of the active study drugs or a placebo. This study will be double blind; this means that neither the subject, nor the study doctor will know which treatment the subject will receive. Which treatment the subject receives is decided by a computer, purely by chance; this is called a "random assignment". For this study, there will first be a screening visit, followed by a 2-week placebo run-in period (all subjects will take placebo once daily). This run-in period is designed to ensure subjects are able to take the study drugs as described in the study protocol. Thereafter there will be a 26-week treatment phase (week 1-week 26) and a 26-week safety extension period (week 27-week 52). Following this there will be a follow-up visit at week 55. On Day 1 after the placebo run-in phase, the subject will be randomly assigned to receive one of the 3 treatments: empagliflozin 10 mg, linagliptin 5 mg or placebo in a blinded manner. This treatment will continue up to week 14. Then after week 14, the subject will be assigned to receive one of the following 4 treatments: empagliflozin 10 mg, empagliflozin 25 mg, linagliptin 5 mg or placebo in a blinded manner. The drugs assigned after week 14 will be the same drugs as on Day 1 but some subjects will receive a higher dose of empagliflozin. After the completion of the 26-week treatment period, the subject will enter a 26-week safety extension period. The same active treatment that the subject had been assigned to at week 14 visit will be continued. Subjects assigned to placebo on Day 1 will be randomly assigned to receive one of the 3 active treatments: empagliflozin 10 mg, empagliflozin 25 mg or linagliptin 5 mg in a blinded manner. This safety extension period is primarily designed to provide additional information on how well empagliflozin and linagliptin are tolerated. Following the treatment phases, there will be a follow-up visit at week 55 Intervention model description: Eligible subjects with HbA1c of 6.5% to 10.5% at screening will be randomized in a 1:1:1 ratio to receive empagliflozin 10 mg, linagliptin 5 mg or placebo. HbA1c assessment will be performed at Week 12. All subjects with Week 12 HbA1c < 7% will remain on previously assigned randomized treatment. Subjects taking empagliflozin with Week 12 HbA1c >= 7% will be re-randomized in a 1:1 ratio to continue on the low dose treatment (empagliflozin 10 mg) or up-titrate to the high dose treatment (empagliflozin 25 mg). Subjects taking linagliptin or placebo with Week 12 HbA1c >= 7% will remain on previously assigned treatment. All subjects will get new medication kits dispensed at Week 14 to maintain the blinding. At Week 26, all subjects previously assigned to placebo will be re-randomized in a 1:1:1: ratio to receive one of the active treatments: empagliflozin 10 mg, empagliflozin 25 mg or linagliptin 5 mg. All subjects will get new medication kits dispensed at Week 14 to maintain the blinding.
San Francisco, California and other locations
ObeSity and Jobs in SoCioeconomically Disadvantaged CommUnities: A Randomized CLinical Precision Public HealTh Intervention --The SCULPT-Job Study
Sorry, accepting new patients by invitation only
This is an interventional research study about clinical, psychosocial, and behavioral factors that impact weight loss, weight maintenance, and cardiovascular disease in socially disadvantaged persons.
San Francisco, California
Recent-Onset Type 1 Diabetes Trial Evaluating Efficacy and Safety of Teplizumab
Sorry, in progress, not accepting new patients
The purpose of this study is to determine whether teplizumab slows the loss of β cells and preserves β cell function in children and adolescent 8-17 years old who have been diagnosed with T1D in the previous 6 weeks.. Subjects will receive two courses of either teplizumab or placebo treatment 6 months apart.
San Francisco, California and other locations
Siplizumab in T1DM
Sorry, not currently recruiting here
This is a multicenter, Phase Ib, open-label, siplizumab dose-finding study in individuals aged 8-45 years with a Type 1 diabetes mellitus (T1DM) diagnosis. within 18 months of V0. Participants will be randomized 1:1:1:1 to one of four possible siplizumab dosing arms. All dosing arms will receive weekly siplizumab doses for a total of 12 weeks. After the completion of treatment, participants will undergo follow-up visits at weeks 12, 24, 36 and 52 which include longitudinal MMTTs. Blood samples for mechanistic analyses will be obtained during the treatment phase and thereafter. Adults aged 18- 45 will be enrolled initially at the study sites. The primary objective is to identify a safe, metabolically favorable, dosing regimen for siplizumab in patients with type 1 diabetes that induces changes in T cell phenotypes observed with alefacept therapy in new-onset T1DM. The secondary objectives are to: 1. Assess the safety profile of siplizumab in recently diagnosed T1DM. 2. Assess the effects of siplizumab on residual beta cell function in recently diagnosed T1DM participants.
San Francisco, California and other locations
This Study Will Evaluate the Efficacy, Safety, and Pharmacokinetics of the Port Delivery System With Ranibizumab in Participants With Diabetic Macular Edema Compared With Intravitreal Ranibizumab
Sorry, in progress, not accepting new patients
This study will evaluate the efficacy, safety, and pharmacokinetics of the Port Delivery System with Ranibizumab (PDS) in Participants with Diabetic Macular Edema (DME) when treated every 24 weeks (Q24W) compared with intravitreal ranibizumab 0.5 mg every 4 weeks (Q4W).
San Francisco, California and other locations
Treatment of Type I Diabetes by Islet Transplantation Into the Gastric Submucosa Study Protocol
Sorry, in progress, not accepting new patients
The goal of this trial is to gain initial clinical experience regarding the safety and efficacy of treating type I diabetes in people who have received a kidney transplant by transplanting islets into a new transplant site in the stomach (gastrointestinal submucosa). A total of 6 patients will be enrolled in the study and followed for a period of up to 3 years after the last islet transplant.
San Francisco, California
Validation of the Diabetes Deep Neural Network Score for Diabetes Mellitus Screening
Sorry, not yet accepting patients
The Validation of the Diabetes Deep Neural Network Score (DNN score) for Screening for Type 2 Diabetes Mellitus (diabetes) is a single center, unblinded, observational study to clinically validating a previously developed remote digital biomarker, identified as the DNN score, to screen for diabetes. The previously developed DNN score provides a promising avenue to detect diabetes in these high-risk communities by leveraging photoplethysmography (PPG) technology on the commercial smartphone camera that is highly accessible. Our primary aim is to prospectively clinically validate the PPG DNN algorithm against the reference standards of glycated hemoglobin (HbA1c) for the presence of prevalent diabetes. Our vision is that this clinical trial may ultimately support an application to the Food and Drug Administration so that it can be incorporated into guideline-based screening.
San Francisco, California
Recent-Onset Type 1 Diabetes Extension Study Evaluating the Long-Term Safety of Teplizumab
Sorry, accepting new patients by invitation only
The purpose of this non-interventional extension study is to continue to collect long-term safety and other clinical data for an additional 42 months in participants who completed the PROTECT study.
San Francisco, California and other locations
TEWL Biomarker Study for Diabetic Foot Ulcer Recurrence
Sorry, in progress, not accepting new patients
This is a multicenter study of patients with diabetic foot ulcers (DFU) to develop and validate potential tissue-based biomarkers that predict DFU wound recurrence. Trans-epidermal water loss (TEWL) will be measured on the closed wound site and a location similar to the wound site (reference site). Participants will be enrolled within two weeks after closure of their DFU. Complete wound healing will be verified at a second visit two weeks later and this visit will start the 16 week timeline where participants will be followed weekly by phone until the earliest of DFU wound recurrence or 16 weeks. Participants who experience a DFU wound recurrence and a subset of participants who do not experience a DFU wound recurrence by week 16 will be asked to attend one final visit.
San Francisco, California and other locations
The Impact of Diabetes on REvascularization
Sorry, in progress, not accepting new patients
The presence of foot symptoms at rest or tissue necrosis in patients with peripheral artery disease is a medical urgency and represents a state of critical limb ischemia (CLI) where the risk of amputation, in the absence of revascularization, is high. No trial conducted to date in peripheral revascularization has determined the effect of diabetes on mechanism of revascularization failure. Therefore, this trial represents a unique opportunity to investigate the mechanisms by which diabetes affects surgical and endovascular revascularization procedures with the long-term goal of improving outcomes in CLI.
San Francisco, California and other locations
Our lead scientists for Diabetes research studies include Rick Hecht, MD Andrew Posselt Laura Gottlieb, MD, MPH Galateia Kazakia, PhD Stephen Gitelman, MD Michael Conte, MD Geoff Tison, MD, MPH Laya Ekhlaspour, MD Suneil Koliwad, MD,PhD Danielle Hessler, Ph.D..
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