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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 weeks after start of each intervention
Awards & highlights

Study 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
Select...
I have been diagnosed with prediabetes based on my blood sugar or A1C levels.
Select...
I am between 18 and 50 years old.

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

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%
0%
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

Find a Location

Who is running the clinical trial?

The University of Texas Health Science Center, HoustonLead Sponsor
903 Previous Clinical Trials
320,954 Total Patients Enrolled
28 Trials studying Obesity
15,406 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

In what ways is Cyanocobalamin employed medically?

"Cyanocobalamin is a successful treatment for vitamin deficiency, diabetic neuralgia and can be used to introduce therapeutic doses of vitamins."

Answered by AI

Is Cyanocobalamin a safe health supplement for human consumption?

"The safety of Cyanocobalamin has been rigorously evaluated in a Phase 4 trial and is thus assigned a score of 3."

Answered by AI

What aims are being sought with this medical experiment?

"This clinical trial will gauge the efficacy of various interventions over a span of 6 weeks, primarily by measuring Uncoupling protein 1 (UCP1) levels in adipose tissue. Other metrics used to evaluate outcomes include Interleukin-11 as a cytokine marker, Homeostatic Model Assessment for Insulin Resistance (HOMA-IR), and Suppressor Of Cytokine Signaling 3 band intensity/Western blot from peripheral blood mononuclear cells."

Answered by AI

Could I potentially qualify for participation in this medical trial?

"Prospective participants of this medical trial must possess glucose intolerance and should fall between the ages 18 to 50. This clinical trial is currently in need of about 26 people for enrolment."

Answered by AI

Is the age eligibility for this clinical trial restricted to those over 25 years?

"Based on the parameters set forth in the eligibility criteria, potential patients must be between 18 and 50 years of age to participate."

Answered by AI

Has Cyanocobalamin been investigated in other scientific experiments?

"Currently, 14 separate clinical trials are running to investigate Cyanocobalamin. Of those studies, 4 have advanced into Phase 3 of the trial process. Trials for this medication can be found in 888 different sites across Ōtake, Tokyo."

Answered by AI

What is the cap on participants in this experiment?

"Affirmative, the information on clinicaltrials.gov reveals that this trial is currently enrolling patients. The study was initially uploaded to the database on May 15th 2020 and last modified on September 30th 2022 with a goal of recruiting 26 participants from one research centre."

Answered by AI

Is this experiment in need of additional participants?

"Affirmative. According to the information posted on clinicaltrials.gov, this research is currently in search of test subjects. The study was launched May 15th 2020 and saw its latest alteration September 30th 2022. 26 patients must be enrolled from a single trial site for completion purposes."

Answered by AI

Who else is applying?

What state do they live in?
Texas
What site did they apply to?
The University of Texas Health Science Center at Houston
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
0

Why did patients apply to this trial?

My A1C is out of control. I have diabetes, an am obese. I have tried exercising and can’t seem to lose the weight. Losing weight would bring my A1C down, and help with the diabetes.
PatientReceived 2+ prior treatments

How responsive is this trial?

Typically responds via
Phone Call
Most responsive sites:
  1. The University of Texas Health Science Center at Houston: < 48 hours
Average response time
  • < 2 Days
~5 spots leftby Apr 2025