A Phase 1 interventional study of Placebo and Bethanechol (25 mg) in Type 2 Diabetes Mellitus, sponsored by Washington University School of Medicine. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-05-08.
Sponsored by Washington University School of Medicine · Phase 1, Interventional, and Basic science
Xenin-25 and glucose-dependent insulinotropic polypeptide (GIP) are hormones produced in the intestine that are released into the blood immediately after ingestion of a meal. Together, these 2 hormones increase insulin release and reduce blood glucose levels. Xenin-25 works by increasing acetylcholine release in pancreatic islets. This study will determine if a Bethanechol, a drug that is similar to acetylcholine, also increases insulin release and reduces blood glucose levels after ingestion of a mixed meal.
Each eligible participant will be administered an oral glucose tolerance test (OGTT) so he/she can be assigned to the group with normal glucose tolerance (NGT), impaired glucose tolerance (IGT) which is between normal and diabetic, or type 2 diabetes mellitus (T2DM). Each study subject will then be administered a meal tolerance test (MTT) on 4 separate occasions. For the MTT, a liquid meal (Boost Plus) will be ingested following an overnight fast. A placebo or Bethanechol (25 mg, 50 mg, or 100 mg) will taken by mouth 1 hour before ingestion of the meal. Blood samples will be collected before and during the MTT for the measurement of glucose, insulin, C-peptide, and glucagon levels.
10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.
This study's enrollment of 50 is below the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.
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Exclusion Criteria:
Healthy individuals exhibiting plasma glucose levels less than 140mg/dl two hours after ingestion of 75-g of glucose.
Drug: Placebo · Drug: Bethanechol (25 mg) · Drug: Bethanechol (50 mg) · Drug: Bethanechol (100 mg)
Healthy individuals exhibiting plasma glucose levels between 140 and 199 mg/dl two hours after ingestion of 75-g of glucose.
Drug: Placebo · Drug: Bethanechol (25 mg) · Drug: Bethanechol (50 mg) · Drug: Bethanechol (100 mg)
Healthy individuals exhibiting plasma glucose levels greater than 150 mg/dL under fasting conditions OR greater than 199 mg/dl two hours after ingestion of 75-g of glucose.
Drug: Placebo · Drug: Bethanechol (25 mg) · Drug: Bethanechol (50 mg) · Drug: Bethanechol (100 mg)
A placebo will be taken by mouth 1 hour before ingestion of a mixed meal.
25 mg of Bethanechol will be taken by mouth 1 hour before ingestion of a mixed meal
50 mg of Bethanechol will be taken by mouth 1 hour before ingestion of a mixed meal
100 mg of Bethanechol will be taken by mouth 1 hour before ingestion of a mixed meal
The effects of Bethanechol on insulin secretion rates
Insulin secretion rates (pmoles/min) will be calculated by deconvolution of plasma C-peptide levels. The investigators will then determine if post-prandial insulin secretion rates are greater following administration of Bethanechol compared to placebo.
Time frame: 3 years
This study is completed, as verified in May 2018. You cannot join it, but the record below documents what was studied.
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Washington University School of Medicine