Status:
COMPLETED
Endogenous GLP-1 Secretion on Islet Function in People With and Without Type 2 Diabetes
Lead Sponsor:
Adrian Vella
Collaborating Sponsors:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
Healthy
Type 2 Diabetes
Eligibility:
All Genders
25-65 years
Phase:
PHASE3
Brief Summary
GLP-1 is a hormone made by the body that promotes the production of insulin in response to GLP-1 is produced within the islets expressing prohormone convertase 1/3eating. However, there is increasing ...
Detailed Description
Accumulating evidence suggests that in rodents and humans GLP-1 is synthesized within islets and may act locally in a paracrine fashion. Indeed, mice with genetic loss of intra-islet GLP-1 exhibit dec...
Eligibility Criteria
Inclusion
- Inclusion criteria - non-diabetic subjects:
- Weight-stable, non-diabetic subjects
- Exclusion Criteria - non-diabetic subjects:
- Age \< 25 or \> 65 years (to avoid studying subjects who could have latent type 1 diabetes, or the effects of age extremes in subjects with normal or impaired fasting glucose).
- HbA1c ≥ 6.5%
- Use of glucose-lowering agents.
- For female subjects: positive pregnancy test at the time of enrollment or study
- History of prior upper abdominal surgery such as adjustable gastric banding, pyloroplasty and vagotomy.
- Active systemic illness or malignancy.
- Symptomatic macrovascular or microvascular disease.
- Inclusion criteria - diabetic subjects:
- Weight-stable, diabetic subjects treated with diet and lifestyle alone or with metformin monotherapy
- Exclusion Criteria - diabetic subjects:
- Age \< 25 or \> 65 years (to avoid studying subjects who could have latent type 1 diabetes, or the effects of age extremes in subjects with normal or impaired fasting glucose).
- Use of any glucose-lowering agent other than metformin.
- 2 or more fasting glucose values \> 250mg/dl on medication or after medication withdrawal.
- Unwillingness or inability to withdraw medication for three weeks prior to, and for the duration of the study.
- For female subjects: positive pregnancy test at the time of enrollment or study
- History of prior upper abdominal surgery such as adjustable gastric banding, pyloroplasty and vagotomy.
- Active systemic illness or malignancy.
- Symptomatic macrovascular or microvascular disease.
Exclusion
Key Trial Info
Start Date :
April 15 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2022
Estimated Enrollment :
23 Patients enrolled
Trial Details
Trial ID
NCT04466618
Start Date
April 15 2021
End Date
December 31 2022
Last Update
December 26 2023
Active Locations (1)
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1
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905