Phase 3
Completed N=23
Endogenous GLP-1 Secretion on Islet Function in People With and Without Type 2 Diabetes
Healthy · Type 2 Diabetes
Source: ClinicalTrials.gov NCT04466618 ↗
Enrolled (actual)
23
Serious AEs
0.0%
Results posted
Dec 2023
Primary outcomePrimary: Change in Fasting Glucagon in the Presence or Absence of Exendin-9,39 — 7.4; 7.9; 7.8; 10.2 pmol/l
◆ Published Evidence
Emerging
9citations · ~3 / year
Glucagon-like peptide-1 receptor blockade impairs islet secretion and glucose metabolism in humans.
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 evidence that this hormone might help support the body's ability to produce insulin when diabetes develops. The purpose of this study is to determine the effect of endogenous GLP-1 secretion on insulin secretion in people with and without type 2 diabetes.
Linked Publications
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Glucagon-like peptide-1 receptor blockade impairs islet secretion and glucose metabolism in humans.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Fasting Glucagon in the Presence or Absence of Exendin-9,39 |
7.4; 7.9; 7.8; 10.2 | — |
Eligibility Criteria
Inclusion criteria - non-diabetic subjects:
- Weight-stable, non-diabetic subjects
Exclusion Criteria - non-diabetic subjects:
- Age 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 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.
Data sourced from ClinicalTrials.gov (NCT04466618) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.