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

NCT ID: NCT03018444

Last Updated: 2017-03-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-10-31
• Study Completion Date: 2017-01-31

Brief 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.

Conditions

Diabetes Mellitus, Type 2; Hydroxymethylglutaryl-CoA Reductase Inhibitors

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: TRIPLE

Study Groups

Atorvastatin

2 weeks treatment with Atorvastatin (1st week 40 mg once daily on day, 2nd week 80 mg (2x40mg) once daily)

Group Type: EXPERIMENTAL

Atorvastatin

Intervention Type: DRUG

Atorvastatin tablet

Placebo

2 weeks treatment with placebo tablets of comparable sizes and color to the Atorvastatin tablets (1st week one tablet once daily, 2nd week two tablets once daily)

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

Placebo tablet

Interventions

Atorvastatin

Atorvastatin tablet

Intervention Type: DRUG

Placebo

Placebo tablet

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

University Hospital, Gentofte, Copenhagen

OTHER

Sponsor Role: lead

Responsible Party

Filip Krag Knop

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Filip K. Knop, Professor MD

Role: PRINCIPAL_INVESTIGATOR

Department of Clinical Medicine, University of Copenhagen, Gentofte Hospital

Locations

University Hospital, Gentofte, Copenhagen

Hellerup, Capital Region, Denmark

Countries

Denmark

Other Identifiers

H-16034243

Identifier Type: -

Identifier Source: org_study_id