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

Primary Purpose

Diabetes Mellitus, Type 2, Hydroxymethylglutaryl-CoA Reductase Inhibitors

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Atorvastatin
Placebo
Sponsored by
University Hospital, Gentofte, Copenhagen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Diabetes Mellitus, Type 2

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)MaleAccepts 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

Sites / Locations

  • University Hospital, Gentofte, Copenhagen

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Atorvastatin

Placebo

Arm Description

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

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)

Outcomes

Primary Outcome Measures

Postprandial GLP-1 secretion

Secondary Outcome Measures

Postprandial Bile Acid Composition
Postprandial total plasma Bile Acid
Postprandial Glucose Tolerance
Postprandial plasma lipid response
Postprandial GIP secretion
Enteric hormones known to influence glucose metabolism
Gallbladder emptying
Faecal content of bile acid
Gut microbiota composition
Gastric emptying
Resting Energy Expenditure

Full Information

First Posted
January 10, 2017
Last Updated
March 2, 2017
Sponsor
University Hospital, Gentofte, Copenhagen
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1. Study Identification

Unique Protocol Identification Number
NCT03018444
Brief Title
The Effect of HMG-CoA Reductase Inhibition on Postprandial GLP-1 Secretion
Official Title
The Effect of HMG-CoA Reductase Inhibition on Postprandial GLP-1 Secretion
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
October 2016 (undefined)
Primary Completion Date
January 2017 (Actual)
Study Completion Date
January 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital, Gentofte, Copenhagen

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2, Hydroxymethylglutaryl-CoA Reductase Inhibitors

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Atorvastatin
Arm Type
Experimental
Arm Description
2 weeks treatment with Atorvastatin (1st week 40 mg once daily on day, 2nd week 80 mg (2x40mg) once daily)
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm 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)
Intervention Type
Drug
Intervention Name(s)
Atorvastatin
Intervention Description
Atorvastatin tablet
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Placebo tablet
Primary Outcome Measure Information:
Title
Postprandial GLP-1 secretion
Time Frame
240 min
Secondary Outcome Measure Information:
Title
Postprandial Bile Acid Composition
Time Frame
240 min
Title
Postprandial total plasma Bile Acid
Time Frame
240 min
Title
Postprandial Glucose Tolerance
Time Frame
240 min
Title
Postprandial plasma lipid response
Time Frame
240 min
Title
Postprandial GIP secretion
Time Frame
240 min
Title
Enteric hormones known to influence glucose metabolism
Time Frame
240 min
Title
Gallbladder emptying
Time Frame
240 min
Title
Faecal content of bile acid
Time Frame
One sample collected on day 12 or 13 of the intervention
Title
Gut microbiota composition
Time Frame
One sample collected on day 12 or 13 of the intervention
Title
Gastric emptying
Time Frame
240 min
Title
Resting Energy Expenditure
Time Frame
At time -20 min, +60 min and +220 min

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Filip K. Knop, Professor MD
Organizational Affiliation
Department of Clinical Medicine, University of Copenhagen, Gentofte Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital, Gentofte, Copenhagen
City
Hellerup
State/Province
Region Hovedstaden
ZIP/Postal Code
2900
Country
Denmark

12. IPD Sharing Statement

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

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