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The Effects of Bethanechol on Glucose Homeostasis

Information source: Washington University School of Medicine
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Type 2 Diabetes Mellitus

Intervention: Placebo (Drug); Bethanechol (25 mg) (Drug); Bethanechol (50 mg) (Drug); Bethanechol (100 mg) (Drug)

Phase: Phase 1

Status: Active, not recruiting

Sponsored by: Washington University School of Medicine

Official(s) and/or principal investigator(s):
Burton M Wice, PhD, Principal Investigator, Affiliation: Washington University School of Medicine
Dominic Reeds, MD, Principal Investigator, Affiliation: Washington University School of Medicine

Summary

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.

Clinical Details

Official title: The Effects of Bethanechol, a Muscarinic Agonist, on Plasma Insulin, Glucagon, and Glucose Levels in Humans With and Without Type 2 Diabetes Mellitus

Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Basic Science

Primary outcome: The effects of Bethanechol on insulin secretion rates

Detailed description: 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.

Eligibility

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Ages 18-65. No minors will be studied.

- Individuals must be able to consent for their own participation (no mental impairment

affecting cognition or willingness to follow study instructions).

- Healthy volunteers with no clinical evidence of T2DM (see below).

- Otherwise healthy volunteers that have impaired glucose tolerance (see below).

- Otherwise healthy volunteers with Diet Controlled T2DM (see below).

- Otherwise healthy volunteers with T2DM that take oral agents only and if the

subject's pre-existing oral anti-diabetic agents can be safely discontinued for 48 hours prior to Oral Glucose Tolerance Test.

- Otherwise healthy volunteers with T2DM who do not use insulin for blood glucose

control.

- Persons with HbA1c ≤ 9%.

- Women of childbearing potential must be currently taking/using a method of birth

control that is acceptable to the investigators. A pregnancy test will be done at the beginning of each visit. Any woman with a positive pregnancy test will be removed from the study. Exclusion Criteria:

- <18years of age or >65 years of age

- Lacks cognitive ability to sign the consent &/or follow the study directions for

themselves

- Women unwilling to comply with using an acceptable method of contraception during the

course of the study, or who are currently breast-feeding.

- Any subject whose screening HbA1c is >9. 0%

- Type 2 diabetes requiring the use of supplemental insulin @ home

- Volunteers with a history of Acute Pancreatitis

- Volunteer with a history of Chronic Pancreatitis and/or risk factors for chronic

pancreatitis including hypertriglyceridemia (triglycerides >400mg/ml) hypercalcemia (blood calcium level >11. md/dl) and/or the presence of gallstones.

- Volunteers with a history of gastrointestinal disorders, particularly related to

gastric motility/emptying such as gastric bypass, documented gastro-paresis in diabetic volunteers.

- Volunteers with a history of cancer. Exception: skin cancer.

- Diabetics that have the potential to have a low blood sugar without them being aware

that their blood sugar is low (hypoglycemia unawareness).

- Known heart, kidney. liver or pancreatic disease requiring medications.

- Unwillingness to allow blood glucose level adjustment (if needed) with IV insulin.

- Subjects with hyperthyroidism, coronary artery disease, peptic ulcer, asthma, chronic

bronchitis, or COPD.

Locations and Contacts

Washington University School of Medicine, St. Louis, Missouri 63131, United States
Additional Information

Starting date: May 2011
Last updated: June 11, 2015

Page last updated: August 23, 2015

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