Exendin 9-39 for Prediabetes

Overseen By Adrian Vella, MD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Mayo Clinic

Must not be taking: Glucose-lowering agents

Disqualifiers: Age < 25 or > 70, HbA1c > 6.5%, Pregnancy, Abdominal surgery, Active illness, Vascular disease, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

Duration: 0-240 minutes

60 Participants Needed

Trial Summary

What is the purpose of this trial?

We recently demonstrated that blockade of Glucagon-Like Peptide-1's (GLP-1) receptor (GLP1R) results in changes in islet function without changes in circulating GLP-1. These effects are more pronounced in people with early type 2 diabetes (T2DM) in keeping with increased expression of PC-1/3 and GLP-1 that is observed in diabetic islets. However, its regulation is at present unknown. At present it is unknown if these abnormalities develop in prediabetes and whether they contribute to the phenotypes observed. In this experiment we will use blockade of GLP1R to probe the contribution of endogenous GLP-1 secretion to the regulation of fasting glucose and islet function in prediabetes.

Research Team

Adrian Vella, MD

Principal Investigator

Mayo Clinic

Eligibility Criteria

This trial is for individuals with prediabetes or impaired glucose tolerance, possibly related to Polycystic Ovary Syndrome (PCOS). Participants should have early signs of blood sugar regulation issues but not full-blown type 2 diabetes. Specific inclusion and exclusion criteria details are not provided.

Inclusion Criteria

2hr glucose after 75g OGTT less than 200 mg/dL

People with stable weight and no history of diabetes

Fasting glucose less than 126 mg/dL

Exclusion Criteria

I am either younger than 25 or older than 70.

I have another active illness or cancer.

HbA1c greater than 6.5%

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either exendin 9-39 or saline to study the role of GLP-1 in prediabetes

0-240 minutes

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Exendin 9-39

Trial Overview The study tests the effects of blocking GLP-1 receptors in the body using a substance called Exendin 9-39 compared to a saline solution. The goal is to understand how this blockade affects fasting glucose levels and the function of insulin-producing cells in those with prediabetes.

Participant Groups

Group I: Exendin 9-39 Active Control 1 Intervention

Subjects will receive exendin 9-39 during the study

Group II: Saline Placebo Group 1 Intervention

Subjects will receive saline during the study

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+