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Completed

NCT Number: NCT03018444

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

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.

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Key information

Conditions

Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Hydroxymethylglutaryl-CoA Reductase Inhibitors Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–70 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital, Gentofte, Copenhagen

Hellerup, Capital Region, 2900, Denmark

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

atorvastatin

Drug

Atorvastatin tablet

Placebo

Other

Placebo tablet

Primary outcomes

  1. Postprandial GLP-1 secretion

    Time frame: 240 min

Secondary outcomes

  1. Postprandial Bile Acid Composition

    Time frame: 240 min

  2. Postprandial total plasma Bile Acid

    Time frame: 240 min

  3. Postprandial Glucose Tolerance

    Time frame: 240 min

  4. Postprandial plasma lipid response

    Time frame: 240 min

  5. Postprandial GIP secretion

    Time frame: 240 min

  6. Enteric hormones known to influence glucose metabolism

    Time frame: 240 min

  7. Gallbladder emptying

    Time frame: 240 min

  8. Faecal content of bile acid

    Time frame: One sample collected on day 12 or 13 of the intervention

  9. Gut microbiota composition

    Time frame: One sample collected on day 12 or 13 of the intervention

  10. Gastric emptying

    Time frame: 240 min

  11. Resting Energy Expenditure

    Time frame: At time -20 min, +60 min and +220 min

Sponsors and collaborators

Lead sponsor

University Hospital, Gentofte, Copenhagen

Other

Registry information

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Jan 12, 2017
Registry last updated
Mar 3, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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