The Effect of HMG-CoA Reductase Inhibition on Postprandial GLP-1 Secretion

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

The Effect of HMG-CoA Reductase Inhibition on Postprandial GLP-1 Secretion

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03018444
• Other study ID #: H-16034243
• Status: Completed
• Phase: N/A
• First received: January 10, 2017
• Last updated: March 2, 2017
• Start date: October 2016
• Est. completion date: January 2017

Study information

• Verified date: March 2017
• Source: University Hospital, Gentofte, Copenhagen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The primary objective of the present study is to evaluate the effect of HMG-CoA reductase inhibition during 14 days on the postprandial plasma GLP-1 response in healthy individuals. Secondary objectives include the evaluation of HMG-CoA reductase inhibition on postprandial glucose tolerance, gallbladder emptying, gastric emptying, plasma responses of lipids, bile acids and pancreatic and enteric hormones known to influence glucose metabolism and appetite, and faecal content of bile acids and gut microbiota composition.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: January 2017
• Est. primary completion date: January 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Body mass index (BMI) >18.5 kg/m2 and <35 kg/m2

• Caucasian ethnicity

• Normal haemoglobin

• Glycated haemoglobin (HbA1c) <43 mmol/mol

• Fasting plasma glucose <6 mmol/l

• Informed and written consent

Exclusion Criteria:

• Diabetes

• First-degree relatives with diabetes (both type 1 diabetes and type 2 diabetes)

• Liver disease (serum alanine aminotransferase (ALAT) and/or serum aspartate aminotransferase (ASAT) >2 times normal values) or history of hepatobiliary disorder

• Gastrointestinal disease, previous intestinal resection, cholecystectomy or any major intra-abdominal surgery

• Reduced kidney function or nephropathy (estimated glomerular filtration rate (eGFR) <60 ml/min/1.73 m2 (based on serum creatinine) and/or albuminuria

• Taking any kind of medicine on a regular basis

• Intake of antibiotics two months prior to study

• Active or recent malignant disease

• Any treatment or condition requiring acute or sub-acute medical or surgical intervention

• Any condition considered incompatible with participation by the investigators

• If the subjects receive any antibiotic treatment while included in the study they will be excluded

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Hydroxymethylglutaryl-CoA Reductase Inhibitors

Intervention

Drug:
• Atorvastatin
Atorvastatin tablet

Other:
• Placebo
Placebo tablet

Locations

Country	Name	City	State
Denmark	University Hospital, Gentofte, Copenhagen	Hellerup	Region Hovedstaden

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Gentofte, Copenhagen

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postprandial GLP-1 secretion		240 min
Secondary	Postprandial Bile Acid Composition		240 min
Secondary	Postprandial total plasma Bile Acid		240 min
Secondary	Postprandial Glucose Tolerance		240 min
Secondary	Postprandial plasma lipid response		240 min
Secondary	Postprandial GIP secretion		240 min
Secondary	Enteric hormones known to influence glucose metabolism		240 min
Secondary	Gallbladder emptying		240 min
Secondary	Faecal content of bile acid		One sample collected on day 12 or 13 of the intervention
Secondary	Gut microbiota composition		One sample collected on day 12 or 13 of the intervention
Secondary	Gastric emptying		240 min
Secondary	Resting Energy Expenditure		At time -20 min, +60 min and +220 min