Current partner codePEPTIDESDE
NCT01656057·Not applicable·INTERVENTIONAL

The Impact of Gall Bladder Emptying and Bile Acids on the Human GLP-1-secretion

Status

Completed

Phase

Not applicable

Enrollment

10

Locations

1

Results

Not posted

Publications

1

Study summary

What the protocol is testing.

The last couple of years it has been shown that bile acids not only acts as simple emulsifiers of fat, but constitutes a complex metabolic integrator which not only have an influence on fat digestion and lipid metabolism, but also modulates the energy expenditure in (brown) adipose tissue and muscle tissue. This action is due to stimulation of the receptor TGR5 by bile acids. Recently scientists have discovered that this receptor in rodents is also expressed on the surface of intestinal L-cells (which normally secrets Glucagon-Like Peptide-1 (GLP-1) in response to nutrient stimulation). The stimulation of this receptor has shown a GLP-1 secretion from the intestinal cells which is interesting since GLP-1 has a central role in maintaining normal glucose tolerance and thus blood sugar. Given the above, bile acids has an important impact on intestinal GLP-1 secretion. Whether these scientific findings can be proven in human beings is uncertain. The primary hypothesis is that stimulating gall bladder emptying via Cholecystokinin (CCK) in healthy subjects will result in a significant GLP-1 response. We also hypothesize that adding orally Metformin or a sequestrant ("a bile acid binder") will further enhance this GLP-1 response.

Interventions

Treatment arms and agents.

DRUG

Acetaminophen

Acetaminophen dissolved in 50 ml of water

DRUG

Metformin

Metformin + acetaminophen dissolved in 50 ml of water

DRUG

Colesevelam

Colesevelam + acetaminophen dissolved in 50 ml of water

OTHER

Cholecystokinin-8

iv. infusion of CCK-8, 24 pmol/kg/hour for the first 60 minutes

OTHER

Saline

iv. saline infusion 40 ml/hour for the first 60 minutes

Timeline

From registration to results.

  1. First posted

    Aug 2, 2012

  2. Study start

    Jul 2012

  3. Primary completion

    Oct 2013

  4. Study completion

    Apr 2014

  5. Results posted

    Not reported

  6. Registry updated

    Jul 14, 2015

Outcomes

What the study measures.

Primary outcomes

GLP-1 response as incremental area under curve (iAUC)

Time frame · -30, -15, 0, 10, 20, 30, 40, 50, 60, 90, 120, 150, 180, 240

Secondary outcomes

Insulin

Time frame · -30, -15, 0, 10, 20, 30, 40, 50, 60, 90, 120, 150, 180, 240

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
40 Years
Sex
MALE
Healthy volunteers
Yes

Inclusion Criteria: * HbA1c \< 6,0% * Not anaemic * Written informed consent Exclusion Criteria: * Liver disease * Nephropathy * fasting plasma glucose \> 5,6mM * Diabetes running in the family (parents or grandparents) * Any medical treatment * A former medical history of liver- or bile disease * any surgical procedure conducted in the abdomen * Body mass index \< 18,5 kg/m2 or \> 25 kg/m2

Study locations

1 registered sites.

Denmark. Showing up to 24 locations stored in the fast local snapshot.

University Hospital of Copenhagen, Gentofte Hospital, Diabetic Research Division

Copenhagen, Hellerup, Denmark

Related trials

More studies on Sincalide.

Related PeptideStat pages

Put the record in context.

Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.