Type 2 DiabetesNCT02061124
Effect of Bile Acid Sequestration on Postprandial GLP-1 Secretion, Glucose Homeostasis and Gut Microbiota
A study testing Sevelamer 1600 mg TID for 7 days in people with Type 2 Diabetes, run by University Hospital, Gentofte, Copenhagen at 1 site in Denmark.
Trial summary
Accumulating evidence suggests that bile acids and bacteria in our intestines may constitute essential components in the complex mechanisms regulating gut hormone secretion and glucose homeostasis. At the same time, bile acids and gut bacteria are interdependent. Read more about this study
- Who is it for?
- Ages 35 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Sevelamer 1600 mg TID for 7 days
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteDenmark
- Study dates
- Feb 2014to Oct 2015
- 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 35 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Both groups
- Caucasian ethnicity
- Normal haemoglobin
- Age above 35 years and below 80 years
- Informed and written consent
- BMI > 23 kg/m2 and <35 kg/m2
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- Patients with type 2 diabetes
- Type 2 diabetes for at least 3 months
- Diagnosed according to the criteria of the World Health Organization (WHO)
- Healthy Subjects
- Normal fasting plasma glucose (FPG) <6.5 mM and
- Normal glycated haemoglobin (HbA1c) <6.0 %
Who cannot join
- Both groups
- Liver disease (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
- Hypo- or hyperphosphataemia
- Nephropathy (serum creatinine >150 µM and/or albuminuria
- Treatment with medicine that cannot be paused for 12 hours
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- Intake of antibiotics six months prior to study
- Hypo- or hypercalcaemia
- Hypo- and hyperthyroidism
- Treatment with oral anticoagulants
- Active or recent malignant disease
- Any treatment or condition requiring acute or sub-acute medical or surgical intervention
- Lack of effective birth control in premenopausal women
- Positive pregnancy test on study days in premenopausal women
- Tobacco smoking
- Any condition considered incompatible with participation by the investigators
- Patients with type 2 diabetes
- Treatment with insulin
- Treatment with incretin-based therapy
- Healthy Subjects
- Diabetes or
- prediabetes (fasting plasma glucose levels >6.5 mM or HbA1c >6.0%)
- First-degree relatives with diabetes
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Diabetes Research Division, Gentofte Hospital, Copenhagen
Hellerup, 2900
About this study
Accumulating evidence suggests that bile acids and bacteria in our intestines may constitute essential components in the complex mechanisms regulating gut hormone secretion and glucose homeostasis. At the same time, bile acids and gut bacteria are interdependent. Thus, it is likely that modification of the enterohepatic circulation of bile acids can lead to changes in gut hormone secretion or gut bacteria composition and consequently affect glucose homeostasis.
The current study is a human interventional study with 7-day ingestion of a bile acid sequestrant or placebo, preceded and followed by meal tests and faecal sampling. The aim is to examine how (and if) bile acid sequestration can influence postprandial glucagon-like peptide-1 (GLP-1) secretion, gut microbiota and glucose homeostasis in patients with type 2 diabetes and healthy individuals. As a tool to sequester bile acids we will use sevelamer, a phosphate binding resin used in the treatment of hyperphosphataemia in adult patients with chronic kidney disease. Surprisingly, sevelamer was recently shown to improve glycaemic control in patients with chronic kidney disease and type 2 diabetes.
The investigators hypothesize that higher luminal concentrations of bile acids in the distal gut will elicit changes in the postprandial gut hormone secretion and gut bacteria composition. The current study will help to clarify this hypothesis and improve our general understanding of the association between bile acid circulation and signalling, gut hormone secretion, gut bacteria and glucose metabolism.
- Conditions
- Type 2 Diabetes
- Being tested
- Sevelamer 1600 mg TID for 7 days, Placebo 1600 mg TID for 7 days
- 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.
Sevelamer 1600 mg TID for 7 daysDrug
Placebo 1600 mg TID for 7 daysDrug
| Study group | Role | What they receive |
|---|---|---|
| T2DM, sevelamer | Active comparator | Patients with type 2 diabetes treated with sevelamer Receives: Drug: Sevelamer 1600 mg TID for 7 days |
| T2DM, placebo | Placebo comparator | Patients with type 2 diabetes treated with placebo Receives: Drug: Placebo 1600 mg TID for 7 days |
| Healthy subjects, sevelamer | Active comparator | Healthy subjects treated with sevelamer Receives: Drug: Sevelamer 1600 mg TID for 7 days |
| Healthy subjects, placebo | Placebo comparator | Healthy subjects treated with placebo Receives: Drug: Placebo 1600 mg TID for 7 days |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incremental and total area under the Concentration-Time Curve (AUC 0-240 min)
Postprandial responses of glucagon-like peptide-1 (GLP-1)
Measured: -30, -15, 0, 10, 20, 30, 45, 60, 90, 120, 180, 240 min on study days 1 and 7 (meal tests start at 0 min)
Secondary outcomes (1)
Incremental and total area under the Concentration-Time Curve (AUC 0-240 min)
Postprandial responses of various other gut hormones
Measured: -30, -15, 0, 10, 20, 30, 45, 60, 90, 120, 180, 240 min on study days 1 and 7 (meal tests start at 0 min)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2014 (estimated)
- Study startFeb 2014
- Primary completionOct 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Gentofte, Copenhagen
- Sponsor type
- University, hospital or other
- Collaborators
- Sanofi
- Responsible party
- Principal investigator, Andreas Brønden, University Hospital, Gentofte, Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02061124
- Sponsor's protocol ID
- H-2-2013-148
- Status last verified
- Nov 2015
- First submitted
- 6 Feb 2014
- Last updated
- 23 Nov 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Bile Acid Sequestration on Postprandial GLP-1 Secretion, Glucose Homeostasis and Gut Microbiota
- ClinicalTrials.gov ID
- NCT02061124
- Acronym / sponsor ID
- H-2-2013-148
- Conditions
- Type 2 Diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University Hospital, Gentofte, CopenhagenUniversity, hospital or other
- Collaborators
- Sanofi
- Study start
- Feb 2014
- Primary completion
- Oct 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 12 Feb 2014 (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.
Accumulating evidence suggests that bile acids and bacteria in our intestines may constitute essential components in the complex mechanisms regulating gut hormone secretion and glucose homeostasis. At the same time, bile acids and gut bacteria are interdependent. Thus, it is likely that modification of the enterohepatic circulation of bile acids can lead to changes in gut hormone secretion or gut bacteria composition and consequently affect glucose homeostasis.
The current study is a human interventional study with 7-day ingestion of a bile acid sequestrant or placebo, preceded and followed by meal tests and faecal sampling. The aim is to examine how (and if) bile acid sequestration can influence postprandial glucagon-like peptide-1 (GLP-1) secretion, gut microbiota and glucose homeostasis in patients with type 2 diabetes and healthy individuals. As a tool to sequester bile acids we will use sevelamer, a phosphate binding resin used in the treatment of hyperphosphataemia in adult patients with chronic kidney disease. Surprisingly, sevelamer was recently shown to improve glycaemic control in patients with chronic kidney disease and type 2 diabetes.
The investigators hypothesize that higher luminal concentrations of bile acids in the distal gut will elicit changes in the postprandial gut hormone secretion and gut bacteria composition. The current study will help to clarify this hypothesis and improve our general understanding of the association between bile acid circulation and signalling, gut hormone secretion, gut bacteria and glucose metabolism.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| T2DM, sevelamer | Active comparator | Drug: Sevelamer 1600 mg TID for 7 daysPatients with type 2 diabetes treated with sevelamer |
| T2DM, placebo | Placebo comparator | Drug: Placebo 1600 mg TID for 7 daysPatients with type 2 diabetes treated with placebo |
| Healthy subjects, sevelamer | Active comparator | Drug: Sevelamer 1600 mg TID for 7 daysHealthy subjects treated with sevelamer |
| Healthy subjects, placebo | Placebo comparator | Drug: Placebo 1600 mg TID for 7 daysHealthy subjects treated with placebo |
Who may qualify
- Ages
- 35 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Both groups
- Caucasian ethnicity
- Normal haemoglobin
- Age above 35 years and below 80 years
- Informed and written consent
Key exclusion criteria (23 listed)
- Both groups
- Liver disease (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
- Hypo- or hyperphosphataemia
- Nephropathy (serum creatinine >150 µM 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 |
|---|---|---|
| Sevelamer 1600 mg TID for 7 days | Drug | Healthy subjects, sevelamer, T2DM, sevelamer |
| Placebo 1600 mg TID for 7 days | Drug | Healthy subjects, placebo, T2DM, placebo |
Primary outcome
Incremental and total area under the Concentration-Time Curve (AUC 0-240 min)
Time frame: -30, -15, 0, 10, 20, 30, 45, 60, 90, 120, 180, 240 min on study days 1 and 7 (meal tests start at 0 min)
Postprandial responses of glucagon-like peptide-1 (GLP-1)
1 secondary outcome
Incremental and total area under the Concentration-Time Curve (AUC 0-240 min)
Time frame: -30, -15, 0, 10, 20, 30, 45, 60, 90, 120, 180, 240 min on study days 1 and 7 (meal tests start at 0 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 23 Nov 2015.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sevelamer 1600 mg TID for 7 days in people with Type 2 Diabetes, 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 12 inclusion and 23 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 23 Nov 2015. 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?
Incremental and total area under the Concentration-Time Curve (AUC 0-240 min) (time frame: -30, -15, 0, 10, 20, 30, 45, 60, 90, 120, 180, 240 min on study days 1 and 7 (meal tests start at 0 min)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Nov 2015.