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

University Hospital, Gentofte, Copenhagen

Status: Completed

Conditions: Hydroxymethylglutaryl-CoA Reductase Inhibitors; Diabetes Mellitus, Type 2

Treatments: Drug: Atorvastatin; Other: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT03018444

H-16034243

Details and patient eligibility

About

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.

Enrollment: 15 patients

Sex: Male

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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15 participants in 2 patient groups, including a placebo group

Atorvastatin

Experimental group

Description:

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

Treatment:

Drug: Atorvastatin

Placebo

Placebo Comparator group

Description:

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)

Treatment:

Other: Placebo