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CompletedPhase NA

Effect of Bile Acids on GLP-1 Secretion

Effect of Bile Acids in the Gut on GLP-1 Secretion in Healthy Subjects and Patients With Type 2 Diabetes

Asset

GLP-1 / incretin class catch-all

Listed sites

1

Recruiting sites

-

Actual enrollment

20

Study population

Obesity / overweight, Type 2 diabetes

Eligibility highlights

•BMI ≥25•HbA1c ≤9%•Healthy volunteers

Primary endpoint

•GLP-1

Registered trial locations

Locations reported to ClinicalTrials.gov for this trial snapshot. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT01666223
Org study IDH-1-2012-049

Timeline

Milestones

Study first posted2012-08-16estimated
Last update posted2013-12-24estimated
Study start2012-11 (month precision)
Primary completion2013-06actual (month precision)
Study completion2013-06actual (month precision)

Assets

Investigational agents

GLP-1 / incretin class catch-all

Who this study enrolls

Obesity / overweightType 2 diabetes

Who can enroll

Minimum age18 Years
SexAll
Healthy volunteersAccepted

Inclusion criteria

Patients with type 2 diabetes

Inclusion Criteria:

•danish caucasian ethnicity
•normal haemoglobin
•BMI > 25 kg/m2
•HbA1c < 9%
•informed consent

Exclusion criteria

•liver disease(ALT and AST > upper reference limit)
•gastrointestinal disease
•liver and biliary tract disease
•nephropathy (serum creatinine > 150 μM, and/or albuminuria)
•treatment with insulin, glp-1 analogues and/ or DPP-4 inhibitors
•treatment with medicine that can not be paused for 12 hours
•previous abdominal surgery eg. cholecystectomy
•BMI < 18,5 kg/m2 or > 35 kg/m2

Healthy Volunteers

Inclusion Criteria:

•danish caucasian ethnicity
•normal haemoglobin
•HbA1c < 6,0 (American Diabetes Association guidelines)
•informed consent

Exclusion Criteria:

•liver disease(ALT and AST > upper reference limit)
•gastrointestinal disease
•liver and biliary tract disease
•nephropathy (serum creatinine > 150 μM, and/or albuminuria)
•treatment with medicine that can not be paused for 12 hours
•previous abdominal surgery eg. cholecystectomy
•BMI < 18,5 kg/m2 or > 35 kg/m2
•first degree relatives diagnosed with diabetes
•previously diagnosed with diabetes, or treated with antidiabetic agents

Endpoints (15)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Other (unclassified)
12
Glycemic / diabetes
3

Glycemic / diabetes

3 endpoints
Secondary/protocol endpoint

Change in insulin

Time frame:At baseline, and at 5, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150 and 180 minutes

change from baseline, improvement

Secondary/protocol endpoint

Change in C-peptide

Time frame:At baseline, and at 5, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150 and 180 minutes

change from baseline, improvement

Secondary/protocol endpoint

Change in glucose-dependent insulinotropic polypeptide (GIP)

Time frame:At baseline, and at 5, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150 and 180 minutes

change from baseline, improvement

Other (unclassified)

12 endpoints
Primary/protocol endpoint/low confidence

Change in GLP-1

Time frame:At baseline, and at 5, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150 and 180 minutes

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Change in glucagon

Time frame:At baseline, and at 5, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150 and 180 minutes

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Change in glucagon-like-peptide 2 (GLP-2)

Time frame:At baseline, and at 5, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150 and 180 minutes

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Change in peptide YY (PYY)

Time frame:At baseline, and at 5, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150 and 180 minutes

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Change in oxyntomodulin

Time frame:At baseline, and at 5, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150 and 180 minutes

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Change in bile acids

Time frame:At baseline, and at 5, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150 and 180 minutes

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Change in gastrin

Time frame:At baseline, and at 5, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150 and 180 minutes

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Change in CCK

Time frame:At baseline, and at 5, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150 and 180 minutes

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Change in appetite, satiety and prospective food consumption

Time frame:At baseline, and 30, 60, 90, 120 and 180 minutes

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Change in gallbladder volume

Time frame:-30, 0 (baseline), 30, 60, 120 og 180 minutes

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Change in basal metabolic rate

Time frame:At -30, 60 og 150 minutes

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Change in bile acid composition

Time frame:At -30, 0, 30, 60, 120 og 180 minutes

change from baseline, improvement

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 6, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 6, 2026 snapshot.