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GLP-1 Analog

GLP-1 Therapy for Diabetes

Phase 4

Waitlist Available

Led By Absalon D Gutierrez, MD

Research Sponsored by The University of Texas Health Science Center, Houston

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Diagnosis of Prediabetes - defined as impaired fasting glucose (fasting glucose of 100-125 mg/dL), impaired glucose tolerance (2-hour postprandial blood glucose of 140-199 mg/dL after 75-gram oral glucose challenge), and/or hemoglobin A1C ranging from 5.5% to 6.4%

Men and women, ages 18-50 years

Must not have

History of Type 1 or Type 2 diabetes mellitus

Personal or family history of Leber hereditary optic nerve atrophy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 weeks after start of each intervention

Awards & highlights

Summary

This trial will investigate if a hormone called GLP-1, which is used to treat obesity and diabetes, also causes the body to secrete a protein that could help treat diabetes.

Who is the study for?

Adults aged 18-50 with a BMI ≤ 35 kg/m2 and prediabetes are eligible for this trial. They must not use tobacco, have Type 1 or Type 2 diabetes, be pregnant/breastfeeding, or have serious health issues like uncontrolled thyroid disorders or active cancer. Stable doses of certain medications are required; NSAIDs and antioxidant vitamins must be stopped before the study.Check my eligibility

What is being tested?

The trial is testing whether GLP-1 analogs used in obesity and diabetes treatment can induce IL-6 secretion to form brown fat with anti-diabetic effects. Participants will receive Cyanocobalamin and Dulaglutide to understand how these drugs affect adipose tissue remodeling.See study design

What are the potential side effects?

Possible side effects include digestive discomfort, potential allergic reactions to the medication components, changes in blood sugar levels that could affect energy and mood, as well as other individual-specific responses.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with prediabetes based on my blood sugar or A1C levels.

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I am between 18 and 50 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a history of diabetes.

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I or someone in my family has had Leber hereditary optic nerve atrophy.

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My thyroid condition is not under control.

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I currently have cancer.

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I have a history of serious heart, liver, or kidney disease.

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I have a history of pancreatitis, medullary thyroid cancer, or MEN 2.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 weeks after start of each intervention

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 weeks after start of each intervention

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 weeks after start of each intervention for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Interleukin-6 (IL-6) messenger ribonucleic acid (mRNA) (from adipose tissue)

Signal transducer and activator of transcription 3 (STAT3) band intensity/Western blot (from adipose tissue)

Uncoupling protein 1 (UCP1) (from adipose tissue)

Secondary outcome measures

Beta1-adrenoceptor (ADRB1) (from adipose tissue)

Beta2-adrenoceptor (ADRB2) (from adipose tissue)

Beta3-adrenoceptor (ADRB3) (from adipose tissue)

+19 more

Side effects data

From 2020 Phase 4 trial • 104 Patients • NCT04189848

21%

Nausea

12%

Decreased Appetite

100%

80%

60%

40%

20%

Study treatment Arm

Overall Study

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: DulaglutideExperimental Treatment1 Intervention

Experimental arm

Group II: CyanocobalaminPlacebo Group1 Intervention

Placebo comparator

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Dulaglutide

FDA approved

0 / 8Eligibility criteria met

Find a Location

Who is running the clinical trial?

The University of Texas Health Science Center, HoustonLead Sponsor

919 Previous Clinical Trials

325,018 Total Patients Enrolled

28 Trials studying Obesity

15,378 Patients Enrolled for Obesity

Absalon D Gutierrez, MDPrincipal Investigator - The University of Texas Health Science Center at Houston, Dept. of Medicine

The University of Texas Health Science Center, Houston

1 Previous Clinical Trials

300 Total Patients Enrolled

~4 spots leftby Jul 2025

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