Status:
COMPLETED
GLP-1 Therapy: The Role of IL-6 Signaling and Adipose Tissue Remodeling in Metabolic Response
Lead Sponsor:
The University of Texas Health Science Center, Houston
Collaborating Sponsors:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
Glucose Intolerance
Overweight and Obesity
Eligibility:
All Genders
18-50 years
Phase:
PHASE4
Brief Summary
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...
Detailed Description
Incretins, the analogs of glucagon-like peptide-1 (GLP-1), improve glucose control in type 2 diabetes mellitus and counteract obesity through mechanisms that are not completely understood. The investi...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Men and women, ages 18-50 years
- Diagnosis of Prediabetes - defined as either 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 a hemoglobin A1C ranging from 5.5% to 6.4%.
- BMI ≤ 35 kg/m2
- Women of childbearing age must agree to use an acceptable method of pregnancy prevention (barrier methods, abstinence, oral contraception, vaginal rings, long-acting reversible contraceptives, or surgical sterilization) for the duration of the study
- Patients must have the following laboratory values: Hematocrit ≥ 33 vol%, estimated glomerular filtration rate ≥ 60 mL/min per 1.73 m2, AST (SGOT) \< 2.5 times ULN, ALT (SGPT) \< 2.5 times ULN, alkaline phosphatase \< 2.5 times ULN
- If patients are receiving antihypertensive medications (other than beta blockers) and/or lipid-lowering medications, they must remain on stable doses for the duration of the study.
- If patients are receiving NSAIDs or antioxidant vitamins, these must be discontinued one week prior to study initiation and cannot be restarted during the study.
- If patient takes thyroid medications, these must be dosed to control hypo- or hyperthyroidism.
- Exclusion Criteria:
- History of Type 1 or Type 2 diabetes mellitus
- Pregnant or breastfeeding women
- Medications: Beta blockers, corticosteroids, monoamine oxidase inhibitors, diabetes medications (including incretin mimetics and thiazolidinediones), and/or immunosuppressive therapy over the last 2 months.
- Uncontrolled hypo- or hyperthyroidism
- Current tobacco use
- Active malignancy
- History of clinically significant cardiac, hepatic, or renal disease.
- History of any serious hypersensitivity reaction to study medications, any other incretin mimetic, any other formulation of supplemental vitamin B12, and/or cobalt
- Personal or family history of Leber hereditary optic nerve atrophy
- Prisoners or subjects who are involuntarily incarcerated
- Compulsorily detention for treatment of either a psychiatric or physical (e.g., infectious disease) illness
- Prior history of pancreatitis, medullary thyroid cancer, or multiple endocrine neoplasia type 2 (MEN 2)
- Serum vitamin B12 level above the upper limit of assay detection
Exclusion
Key Trial Info
Start Date :
May 15 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 6 2023
Estimated Enrollment :
23 Patients enrolled
Trial Details
Trial ID
NCT04387201
Start Date
May 15 2020
End Date
October 6 2023
Last Update
December 5 2024
Active Locations (1)
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1
The University of Texas Health Science Center at Houston
Houston, Texas, United States, 77030