NCT03018444

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable diabetes-mellitus-type-2

Timeline
Completed

Started Oct 2016

Shorter than P25 for not_applicable diabetes-mellitus-type-2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2016

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

January 10, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 12, 2017

Completed
Last Updated

March 3, 2017

Status Verified

March 1, 2017

Enrollment Period

3 months

First QC Date

January 10, 2017

Last Update Submit

March 2, 2017

Conditions

Diabetes Mellitus, Type 2Hydroxymethylglutaryl-CoA Reductase Inhibitors

Outcome Measures

Primary Outcomes (1)

  • Postprandial GLP-1 secretion

    240 min

Secondary Outcomes (11)

  • Postprandial Bile Acid Composition

    240 min

  • Postprandial total plasma Bile Acid

    240 min

  • Postprandial Glucose Tolerance

    240 min

  • Postprandial plasma lipid response

    240 min

  • Postprandial GIP secretion

    240 min

  • +6 more secondary outcomes

Study Arms (2)

Atorvastatin

EXPERIMENTAL

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

Drug: Atorvastatin

Placebo

PLACEBO COMPARATOR

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)

Other: Placebo

Interventions

AtorvastatinDRUG

Atorvastatin tablet

Atorvastatin
PlaceboOTHER

Placebo tablet

Placebo

Eligibility Criteria

Age18 Years - 70 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital, Gentofte, Copenhagen

Hellerup, Capital Region, 2900, Denmark

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Atorvastatin

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

PyrrolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeptanoic AcidsFatty AcidsLipids

Study Officials

  • Filip K. Knop, Professor MD

    Department of Clinical Medicine, University of Copenhagen, Gentofte Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 10, 2017

First Posted

January 12, 2017

Study Start

October 1, 2016

Primary Completion

January 1, 2017

Study Completion

January 1, 2017

Last Updated

March 3, 2017

Record last verified: 2017-03

Locations

DK(1)