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GLP-1-mediated Gluco-metabolic Effects of Bile Acid Sequestration

NCT ID: NCT03739268

Last Updated: 2021-10-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

17 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-09-01

Study Completion Date

2021-09-01

Brief Summary

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The objective of this study is to investigate the potential GLP-1-mediated contribution to the well-established glucose-lowering effect of sevelamer-induced bile acid sequestration . Exendin9-39 has been demonstrated to act as a potent and specific GLP-1 receptor antagonist with no partial agonistic potential and is considered a useful tool in the assessment of GLP-1 physiology. The aim is to evaluate any contribution of sevelamer-induced GLP-1 secretion to the reduced plasma glucose concentrations observed after treatment with sevelamer. A randomised placebo-controlled cross-over study involving two 17-day treatment periods with sevelamer and placebo, respectively, in metformin-treated patients with type 2 diabetes, will be conducted. The impact of bile acid sequestration on GLP-1 secretion and effect will be examined during two randomised experimental days after 15 and 17 days of treatment with sevelamer (1,600 mg three times a day) and placebo, respectively. During each of these two experimental days, a meal test with concomitant exendin9-39 infusion or placebo will be performed (for evaluation of any GLP-1-mediated effects). Postprandial plasma glucose excursion is the primary endpoint, and secondary endpoints include postprandial plasma/serum excursions of insulin, C-peptide, GLP-1, glucagon, glucose-dependent insulinotropic polypeptide (GIP), glucagon-like peptide-2 (GLP-2), peptide YY (PYY), oxyntomodulin, ghrelin, fibroblast growth factor (FGF)-19, FGF-21, C4 (an intermediate in the de novo synthesis of bile acids), cholecystokinin (CCK), bile acids and plasma lipids. Furthermore, gastric emptying, gallbladder emptying, liver fat content, appetite and ad libitum food intake will be examined.

Detailed Description

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Conditions

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Type 2 Diabetes Mellitus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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sevelamer

Patients with type 2 diabetes treated with sevelamer

Group Type ACTIVE_COMPARATOR

Sevelamer

Intervention Type DRUG

Sevelamer powder dissolved in water 1,600 mg three times a day for 17 days

placebo

Patients with type 2 diabetes treated with placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

placebo powder dissolved in water 1,600 mg three times a day for 17 days

Interventions

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Sevelamer

Sevelamer powder dissolved in water 1,600 mg three times a day for 17 days

Intervention Type DRUG

Placebo

placebo powder dissolved in water 1,600 mg three times a day for 17 days

Intervention Type DRUG

Other Intervention Names

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Renvela

Eligibility Criteria

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Inclusion Criteria

* Type 2 diabetes for at least 3 months (diagnosed according to the criteria of the World Health Organization (WHO))
* Men and postmenopausal women
* Metformin applied as the only glucose-lowering drug
* Caucasian ethnicity
* Normal haemoglobin
* Age above 40 years and below 75 years
* BMI \>23 kg/m2 and \<35 kg/m2
* Informed and written consent

Exclusion Criteria

* 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
* Nephropathy (serum creatinine \>150 µM and/or albuminuria)
* Hypo- or hyperthyroidism
* Hypo- or hypercalcaemia
* Hypo- or hyperphosphataemia
* Active or recent malignant disease
* Treatment with medicine that cannot be paused for 12 hours
* Treatment with oral anticoagulants
* Any treatment or condition requiring acute or sub-acute medical or surgical intervention
* Any condition considered incompatible with participation by the investigators
Minimum Eligible Age

40 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sanofi

INDUSTRY

Sponsor Role collaborator

Steno Diabetes Center Copenhagen

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Filip K Knop, M.D. PhD

Role: STUDY_DIRECTOR

Steno Diabetes Center Copenhagen

Henriette H Nerild, M.D.

Role: PRINCIPAL_INVESTIGATOR

Steno Diabetes Center Copenhagen

Locations

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Steno Diabetes Center Copenhagen, Gentofte Hospital

Hellerup, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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SeveX2018

Identifier Type: -

Identifier Source: org_study_id