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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
All Individual Drugs Already Approved
Approved for 10 Other Conditions
Drug Has Already Been Approved
Pivotal Trial

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.
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.
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 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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
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 study objectives
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%
0%
Study treatment Arm
Overall Study

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 10 Other Conditions
This treatment demonstrated efficacy for 10 other conditions.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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

Find a Location

Who is running the clinical trial?

The University of Texas Health Science Center, HoustonLead Sponsor
946 Previous Clinical Trials
344,266 Total Patients Enrolled
2 Trials studying Glucose Intolerance
321 Patients Enrolled for Glucose Intolerance
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
1 Trials studying Glucose Intolerance
300 Patients Enrolled for Glucose Intolerance
~4 spots leftby Nov 2025
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