Diabetes Mellitus, Type 2NCT03018444
The Effect of HMG-CoA Reductase Inhibition on Postprandial GLP-1 Secretion
A study testing Atorvastatin in people with Diabetes Mellitus, Type 2 and Hydroxymethylglutaryl-CoA Reductase Inhibitors, run by University Hospital, Gentofte, Copenhagen at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Type 2, Hydroxymethylglutaryl-CoA Reductase Inhibitors
- What is being tested?
- Atorvastatin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- 1 siteDenmark
- Study dates
- Oct 2016to Jan 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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 locations and contacts
1 site in 1 country.
Denmark1 site
University Hospital, Gentofte, Copenhagen
Hellerup, Capital Region, 2900
About this study
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.
- Being tested
- Atorvastatin, Placebo
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AtorvastatinDrug
Atorvastatin tablet
PlaceboOther
Placebo tablet
| Study group | Role | What they receive |
|---|---|---|
| Atorvastatin | Experimental | 2 weeks treatment with Atorvastatin (1st week 40 mg once daily on day, 2nd week 80 mg (2x40mg) once daily) Receives: 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) Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postprandial GLP-1 secretion
Measured: 240 min
Secondary outcomes (11)
Postprandial Bile Acid Composition
Measured: 240 min
Postprandial total plasma Bile Acid
Measured: 240 min
Postprandial Glucose Tolerance
Measured: 240 min
Postprandial plasma lipid response
Measured: 240 min
Postprandial GIP secretion
Measured: 240 min
Enteric hormones known to influence glucose metabolism
Measured: 240 min
Gallbladder emptying
Measured: 240 min
Faecal content of bile acid
Measured: One sample collected on day 12 or 13 of the intervention
Gut microbiota composition
Measured: One sample collected on day 12 or 13 of the intervention
Gastric emptying
Measured: 240 min
Resting Energy Expenditure
Measured: At time -20 min, +60 min and +220 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2017 (estimated)
- Study startOct 2016
- Primary completionJan 2017
- Study completionJan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Gentofte, Copenhagen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Filip Krag Knop, University Hospital, Gentofte, Copenhagen
- Investigators
- Filip K. Knop, Professor MD, Principal investigator, Department of Clinical Medicine, University of Copenhagen, Gentofte Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03018444
- Sponsor's protocol ID
- H-16034243
- Status last verified
- Mar 2017
- First submitted
- 10 Jan 2017
- Last updated
- 3 Mar 2017
- Results posted
- No
Publications
Thomasen M, Misiakou MA, Li SS, Rodriguez de Evgrafov MC, Lynggaard MB, Karhus ML, Bronden A, Kornholt J, Chavez-Talavera O, Tailleux A, Staels B, Descat A, Hartmann B, Wewer Albrechtsen NJ, Rehfeld JF, Holst JJ, Vilsboll T, Ellegaard AM, Sommer MOA, Sonne DP, Knop FK. Metabolic, enterohepatic and gut microbial effects of atorvastatin in healthy men. Endocr Connect. 2026 Mar 9;15(3):e250721. doi: 10.1530/EC-25-0721.
PubMed 41738774
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of HMG-CoA Reductase Inhibition on Postprandial GLP-1 Secretion
- ClinicalTrials.gov ID
- NCT03018444
- Acronym / sponsor ID
- H-16034243
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University Hospital, Gentofte, CopenhagenUniversity, hospital or other
- Study start
- Oct 2016
- Primary completion
- Jan 2017 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 12 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Atorvastatin | Experimental | Drug: Atorvastatin2 weeks treatment with Atorvastatin (1st week 40 mg once daily on day, 2nd week 80 mg (2x40mg) once daily) |
| Placebo | Placebo comparator | Other: Placebo2 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) |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AtorvastatinAtorvastatin tablet | Drug | Atorvastatin |
| PlaceboPlacebo tablet | Other | Placebo |
Primary outcome
Postprandial GLP-1 secretion
Time frame: 240 min
11 secondary outcomes
Postprandial Bile Acid Composition
Time frame: 240 min
Postprandial total plasma Bile Acid
Time frame: 240 min
Postprandial Glucose Tolerance
Time frame: 240 min
Postprandial plasma lipid response
Time frame: 240 min
Postprandial GIP secretion
Time frame: 240 min
Enteric hormones known to influence glucose metabolism
Time frame: 240 min
Gallbladder emptying
Time frame: 240 min
Faecal content of bile acid
Time frame: One sample collected on day 12 or 13 of the intervention
Gut microbiota composition
Time frame: One sample collected on day 12 or 13 of the intervention
Gastric emptying
Time frame: 240 min
Resting Energy Expenditure
Time frame: At time -20 min, +60 min and +220 min
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2017.
- Derived from this study: PubMed 41738774Thomasen M, Misiakou MA, Li SS, Rodriguez de Evgrafov MC, Lynggaard MB, Karhus ML, Bronden A, Kornholt J, Chavez-Talavera O, Tailleux A, Staels B, Descat A, Hartmann B, Wewer Albrechtsen NJ, Rehfeld JF, Holst JJ, Vilsboll T, Ellegaard AM, Sommer MOA, Sonne DP, Knop FK. Metabolic, enterohepatic and gut microbial effects of atorvastatin in healthy men. Endocr Connect. 2026 Mar 9;15(3):e250721. doi: 10.1530/EC-25-0721.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Filip K. Knop, Professor MD principal investigator
Department of Clinical Medicine, University of Copenhagen, Gentofte Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Atorvastatin in people with Diabetes Mellitus, Type 2 and Hydroxymethylglutaryl-CoA Reductase Inhibitors, run by University Hospital, Gentofte, Copenhagen at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postprandial GLP-1 secretion (time frame: 240 min). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03018444, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2017.