Gastrointestinal Motility Clinical Trial
Official title:
Regulation of Antro-pyloro-duodenal and Proximal Gastric Motility by GLP-1: Involvement of Cholinergic Pathways
The purpose of this study in humans is to define the effects of the endogenous hormone GLP-1 on gastroduodenal motility and on endocrine pancreatic secretion by using the specific GLP-1 receptor antagonist exendin(9-39). To elucidate possible cholinergic pathways, we combined exendin(9-39) with the muscarinergic antagonist atropine.
Status | Completed |
Enrollment | 10 |
Est. completion date | September 2000 |
Est. primary completion date | |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years to 65 Years |
Eligibility |
Inclusion Criteria: - Male or female (postmenopausal, surgically sterile or using double-barrier method of contraception) healthy volunteers - Age 18-65 years - Body mass index (BMI) < 30 kg/m2 - Must have a fasting blood glucose below 100 mg/dl at screening and on all study days - Able to provide written informed consent prior to study participation - Able to communicate well with the investigator and comply with the requirements of the study Exclusion Criteria: - Diabetes mellitus - Treatment with systemic steroids and thyroid hormone - Patients with any history of gastrointestinal surgery, e.g. partial bowel resections, partial gastric resections, etc. - Participation in any clinical investigation within 4 weeks prior to dosing or longer if required by local regulation. - Donation or loss of 400 mL or more of blood within 8 weeks prior to dosing. - Significant illness within the two weeks prior to dosing. - Past medical history of clinically significant electrocardiogram (ECG) abnormalities or a family history of a prolonged QT-interval syndrome. - History of clinically significant drug allergy; history of atopic allergy (asthma, urticaria, eczematous dermatitis). A known hypersensitivity to the study drug or drugs similar to the study drug. - Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism or excretion of drugs or which may jeopardize the subject in case of participation in the study. The investigator should be guided by evidence of any of the following: - history of inflammatory bowel syndrome, gastritis, ulcers, gastrointestinal or rectal bleeding - history of major gastrointestinal tract surgery such as gastrectomy, gastroenterostomy, or bowel resection - history or clinical evidence of pancreatic injury or pancreatitis |
Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Diagnostic
Country | Name | City | State |
---|---|---|---|
Germany | Clinical Research unit, Dept. of Internal Medicine II - Großhadern, University of Munich | Munich |
Lead Sponsor | Collaborator |
---|---|
Ludwig-Maximilians - University of Munich | German Research Foundation, Philipps University Marburg Medical Center |
Germany,
Schirra J, Houck P, Wank U, Arnold R, Göke B, Katschinski M. Effects of glucagon-like peptide-1(7-36)amide on antro-pyloro-duodenal motility in the interdigestive state and with duodenal lipid perfusion in humans. Gut. 2000 May;46(5):622-31. — View Citation
Schirra J, Nicolaus M, Roggel R, Katschinski M, Storr M, Woerle HJ, Göke B. Endogenous glucagon-like peptide 1 controls endocrine pancreatic secretion and antro-pyloro-duodenal motility in humans. Gut. 2006 Feb;55(2):243-51. Epub 2005 Jun 28. — View Citation
Schirra J, Sturm K, Leicht P, Arnold R, Göke B, Katschinski M. Exendin(9-39)amide is an antagonist of glucagon-like peptide-1(7-36)amide in humans. J Clin Invest. 1998 Apr 1;101(7):1421-30. — View Citation
Schirra J, Wank U, Arnold R, Göke B, Katschinski M. Effects of glucagon-like peptide-1(7-36)amide on motility and sensation of the proximal stomach in humans. Gut. 2002 Mar;50(3):341-8. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Effect of exendin(9-39) on gastroduodenal motility Effect of exendin(9-39) on gastroduodenal motility with simultaneous atropine | within the 200 min study period | ||
Secondary | Effect of exendin(9-39) on blood glucose levels and plasma immunoreactivities of insulin, glucagon, and pancreatic polypeptide | within the 200 min study period |
Status | Clinical Trial | Phase | |
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