GLP-1 Therapy: The Role of IL-6 Signaling and Adipose Tissue Remodeling in Metabolic Response
Part of paid clinical trials in Houston, Texas.
- Sponsor
- The University of Texas Health Science Center, Houston
- Study ID
- NCT04387201
- Phase
- PHASE4
- Status
- Completed
Conditions
- Adiposity
- Drug Effect
- Glucose Intolerance
- Overweight and Obesity
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 50 Years
- Healthy Volunteers
- Not accepted
Interventions
- Cyanocobalamin — DRUGCyanocobalamin (vitamin B12) 1000 mcg subcutaneous weekly for 6 weeks.
- Dulaglutide — DRUGDulaglutide 0.75 mg subcutaneous weekly for 2 weeks, followed by 1.5 mg subcutaneous weekly for 4 weeks
Study Details
This project investigates the anti-obesity mechanisms of glucagon-like peptide-1 (GLP-1) analogs, which are used in the treatment of human obesity and diabetes mellitus. The investigators will test if GLP-1 induces secretion of interleukin-6 (IL-6), a cytokine that may collaborate with GLP-1 analogs to induce the formation of brown fat, which has anti-diabetic properties. The results will guide future obesity and diabetes mellitus therapies.
Key Dates
- Start date
- May 15, 2020
- Status verified
- Nov 2024
- Primary completion
- Oct 6, 2023
- Completion
- Oct 6, 2023
Study Design
- Enrollment
- 23 participants (actual)
- Allocation
- NON_RANDOMIZED
- Intervention model
- CROSSOVER
- Primary purpose
- BASIC_SCIENCE
Arms
- Experimental: Cyanocobalamin, then DulaglutideParticipants first received Cyanocobalamin (vitamin B12) 1000 mcg subcutaneous weekly for 6 weeks. After a washout period of 3 weeks, they then received Dulaglutide 0.75 mg subcutaneous weekly for 2 weeks, followed by 1.5 mg subcutaneous weekly for 4 weeks
- Experimental: Dulaglutide, then CyanocobalaminParticipants first received Dulaglutide 0.75 mg subcutaneous weekly for 2 weeks, followed by 1.5 mg subcutaneous weekly for 4 weeks. After a washout period of of 3 weeks, they then Cyanocobalamin (vitamin B12) 1000 mcg subcutaneous weekly for 6 weeks.
Primary Outcome Measure
Cytokine Interleukin-6 (IL-6) Messenger Ribonucleic Acid (mRNA) Level (From Adipose Tissue) [ Time Frame: 6 weeks after start of each intervention ]
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| The University of Texas Health Science Center at Houston | Houston | Texas | 77030 | - |
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