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
20 participants
INTERVENTIONAL
2012-11-30
2013-06-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
CROSSOVER
BASIC_SCIENCE
TRIPLE
Study Groups
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Colesevelam
Colesevelam
Colesevelam 3750 mg dissolved in 100 ml saline, administered in a feeding tube at time = 0.
Chenodeoxycholic acid
Chenodeoxycholic Acid
1.250 mg dissolved in 100 ml saline, administered in a feeding tube at time = 0.
Colesevelam + chenodeoxycholic acid
Colesevelam 3750 mg + chenodeoxycholic acid 1250 mg
Colesevelam and chenodeoxycholic acid dissolved in 100 ml saline, administered in a duodenal tube at time = 0.
Placebo
saline
100 ml saline
Interventions
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Colesevelam
Colesevelam 3750 mg dissolved in 100 ml saline, administered in a feeding tube at time = 0.
Chenodeoxycholic Acid
1.250 mg dissolved in 100 ml saline, administered in a feeding tube at time = 0.
saline
100 ml saline
Colesevelam 3750 mg + chenodeoxycholic acid 1250 mg
Colesevelam and chenodeoxycholic acid dissolved in 100 ml saline, administered in a duodenal tube at time = 0.
Eligibility Criteria
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Inclusion Criteria
* normal haemoglobin
* BMI \> 25 kg/m2
* HbA1c \< 9%
* informed consent
* danish caucasian ethnicity
* normal haemoglobin
* HbA1c \< 6,0 (American Diabetes Association guidelines)
* informed consent
Exclusion Criteria
* gastrointestinal disease
* liver and biliary tract disease
* nephropathy (serum creatinine \> 150 μM, and/or albuminuria)
* treatment with insulin, glp-1 analogues and/ or DPP-4 inhibitors
* treatment with medicine that can not be paused for 12 hours
* previous abdominal surgery eg. cholecystectomy
* BMI \< 18,5 kg/m2 or \> 35 kg/m2
Healthy Volunteers
* liver disease(ALT and AST \> upper reference limit)
* gastrointestinal disease
* liver and biliary tract disease
* nephropathy (serum creatinine \> 150 μM, and/or albuminuria)
* treatment with medicine that can not be paused for 12 hours
* previous abdominal surgery eg. cholecystectomy
* BMI \< 18,5 kg/m2 or \> 35 kg/m2
* first degree relatives diagnosed with diabetes
* previously diagnosed with diabetes, or treated with antidiabetic agents
18 Years
ALL
Yes
Sponsors
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University Hospital, Gentofte, Copenhagen
OTHER
Responsible Party
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Morten Hansen
MD, PhD Student
Principal Investigators
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Morten Hansen, MD
Role: PRINCIPAL_INVESTIGATOR
Diabetes Research Division, Department of Internal Medicine, Gentofte Hospital, University of Copenhagen
Locations
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Diabetes Research Division, Department of Internal Medicine, Gentofte Hospital, University of Copenhagen
Hellerup, Copenhagen, Denmark
Countries
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References
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Maruyama T, Miyamoto Y, Nakamura T, Tamai Y, Okada H, Sugiyama E, Nakamura T, Itadani H, Tanaka K. Identification of membrane-type receptor for bile acids (M-BAR). Biochem Biophys Res Commun. 2002 Nov 15;298(5):714-9. doi: 10.1016/s0006-291x(02)02550-0.
Adrian TE, Ballantyne GH, Longo WE, Bilchik AJ, Graham S, Basson MD, Tierney RP, Modlin IM. Deoxycholate is an important releaser of peptide YY and enteroglucagon from the human colon. Gut. 1993 Sep;34(9):1219-24. doi: 10.1136/gut.34.9.1219.
Katsuma S, Hirasawa A, Tsujimoto G. Bile acids promote glucagon-like peptide-1 secretion through TGR5 in a murine enteroendocrine cell line STC-1. Biochem Biophys Res Commun. 2005 Apr 1;329(1):386-90. doi: 10.1016/j.bbrc.2005.01.139.
Rafferty EP, Wylie AR, Hand KH, Elliott CE, Grieve DJ, Green BD. Investigating the effects of physiological bile acids on GLP-1 secretion and glucose tolerance in normal and GLP-1R(-/-) mice. Biol Chem. 2011 Apr;392(6):539-46. doi: 10.1515/BC.2011.050. Epub 2011 Apr 27.
Other Identifiers
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H-1-2012-049
Identifier Type: -
Identifier Source: org_study_id