Effect of Metformin and Cholecystokinin-mediated Gallbladder Emptying on GLP-1 Secretion in Type 2 Diabetes
NCT ID: NCT02497313
Last Updated: 2017-05-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
15 participants
INTERVENTIONAL
2015-07-31
2016-07-31
Brief Summary
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The current study is a human interventional randomized controlled cross-over study including four study days for each participant. Metformin will be applied as a tool to reduce bile acid reuptake in the small intestine; thereby increasing bile acid concentration in the more distal parts of the gut where GLP-1-secreting L cell are abundant. Interestingly, metformin has been shown to reduce the active reabsorption of bile acids in the ileum and cause increased faecal elimination of bile acids. Clinical data has suggested that metformin causes an increase in the postprandial secretion of GLP-1 in humans including patients with type 2 diabetes. Intravenous infusion of cholecystokinin will be used to elicit gallbladder contraction and emptying. The aim is to examine how (and if) modification of bile acid reabsorption can influence postprandial glucagon-like peptide-1 (GLP-1) secretion and glucose homeostasis in patients with type 2 diabetes.
The investigators hypothesize that higher luminal concentrations of bile acids in the distal gut will elicit changes in gut hormone secretion. The current study will help to clarify this hypothesis and improve our general understanding of the association between bile acid circulation and signalling, gut hormone secretion and glucose metabolism.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
BASIC_SCIENCE
DOUBLE
Study Groups
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Placebo+Placebo
Oral ingestion of metformin placebo combined with intravenous infusion of isotonic saline.
Isotonic saline
Metformin placebo
Placebo+Cholecystokinin
Oral ingestion of metformin placebo combined with intravenous infusion of cholecystokinin.
Metformin placebo
Cholecystokinin
Metformin+Placebo
Oral ingestion of metformin combined with intravenous infusion of isotonic saline.
Isotonic saline
Metformin
Metformin+Cholecystokinin
Oral ingestion of metformin combined with intravenous infusion of cholecystokinin.
Cholecystokinin
Metformin
Interventions
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Isotonic saline
Metformin placebo
Cholecystokinin
Metformin
Eligibility Criteria
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Inclusion Criteria
* Men and postmenopausal women
* Metformin applied as the only anti-diabetic drug
* Caucasian ethnicity
* Normal haemoglobin
* BMI \>23 kg/m2 and \<35 kg/m2
* Informed and written consent
Exclusion Criteria
* Gastrointestinal disease, previous intestinal resection, cholecystectomy or any major intra-abdominal surgery
* Nephropathy (serum creatinine \>150 µM and/or albuminuria)
* Hypo- and hyperthyroidism
* Hypo- and hypercalcaemia
* Hypo- and hyperphosphataemia
* Active or recent malignant disease
* Treatment with medicine that cannot be paused for 12 hours
* Treatment with oral anticoagulants
* Any treatment or condition requiring acute or sub-acute medical or surgical intervention
* Any condition considered incompatible with participation by the investigators
40 Years
75 Years
ALL
No
Sponsors
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University Hospital, Gentofte, Copenhagen
OTHER
Responsible Party
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Andreas Brønden
MD
Principal Investigators
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Andreas Brønden, MD
Role: PRINCIPAL_INVESTIGATOR
PhD student
Locations
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Center for Diabetes Research, Herlev-Gentofte Hospital
Hellerup, , Denmark
Countries
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References
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Bronden A, Alber A, Rohde U, Rehfeld JF, Holst JJ, Vilsboll T, Knop FK. Single-Dose Metformin Enhances Bile Acid-Induced Glucagon-Like Peptide-1 Secretion in Patients With Type 2 Diabetes. J Clin Endocrinol Metab. 2017 Nov 1;102(11):4153-4162. doi: 10.1210/jc.2017-01091.
Other Identifiers
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H-15007280
Identifier Type: -
Identifier Source: org_study_id
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