Delineation of the Role of Glucagon-like Peptide-1 Signalling in Relation to Increased Carbohydrate Content in the Distal Small Intestines

NCT ID: NCT03241303

Last Updated: 2020-03-26

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

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-08-01

Study Completion Date

2018-01-01

Brief Summary

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Investigation of GLP-1 signalling in the glucose-lowering effect of increased carbohydrate content in the distal small intestines induced by alpha-glucosidase inhibition during meal ingestion in patients with type 2 diabetes

Detailed Description

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The primary aim of the study is to investigate whether GLP-1 released as a result of increased carbohydrate content in the distal and L cell-rich part of the small intestine after a meal affects postprandial plasma glucose levels in patients with type 2 diabetes. This will be done by applying an alpha-glucosidase inhibitor (to increase the postprandial carbohydrate content in the distal small intestine) and the specific GLP-1 receptor antagonist exendin(9-39) (to isolate any GLP-1-mediated effects) during meal tests in patients with type 2 diabetes.

Conditions

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Glucose Metabolism Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Acarbose

50 mg and 100 mg glucobay tablets. 2 weeks. Other name: Precose

Group Type EXPERIMENTAL

Acarbose

Intervention Type DRUG

Glucobay tablets on experimental day.

Placebo Oral tablets

180 mg. 2 weeks.

Group Type PLACEBO_COMPARATOR

Placebo Oral Tablet

Intervention Type DRUG

Placebo tablets on experimental day.

Exendin (9-39)

Infusion of GLP-1 receptor antagonist as a study tool to block GLP-1 activity on experimental day.

Group Type EXPERIMENTAL

Exendin (9-39)

Intervention Type DRUG

Infusion of GLP-1 receptor antagonist as a study tool to block GLP-1 activity on experimental day.

Placbo Saline

9 mg/ml placebo saline infusion on experimental day.

Group Type PLACEBO_COMPARATOR

Placebo Saline

Intervention Type DRUG

9 mg/ml placebo saline infusion on experimental day.

Interventions

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Acarbose

Glucobay tablets on experimental day.

Intervention Type DRUG

Placebo Oral Tablet

Placebo tablets on experimental day.

Intervention Type DRUG

Exendin (9-39)

Infusion of GLP-1 receptor antagonist as a study tool to block GLP-1 activity on experimental day.

Intervention Type DRUG

Placebo Saline

9 mg/ml placebo saline infusion on experimental day.

Intervention Type DRUG

Other Intervention Names

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Glucobay, Precose Ex(9-39)

Eligibility Criteria

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Inclusion Criteria

* Type 2 diabetes for at least three months (diagnosed according to the criteria of the World Health Organization (WHO)) treated with metformin monotherapy
* Caucasian ethnicity
* Normal haemoglobin
* Age \>18 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
* Reduced kidney function or nephropathy (estimated glomerular filtration rate (eGFR) \<60 ml/min/1.73 m2 (based on serum creatinine) and/or albuminuria
* Treatment with medicine that cannot be paused for 12 hours
* Intake of antibiotics two months prior to study
* Treatment with glucose-lowering drugs other than metformin
* 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
* Pregnancy
* Women who are breastfeeding
* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Copenhagen

OTHER

Sponsor Role collaborator

University Hospital, Gentofte, Copenhagen

OTHER

Sponsor Role lead

Responsible Party

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Niels Bjørn Dalsgaard

Bachelor of Science

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Filip K Knop, MD, PhD

Role: STUDY_DIRECTOR

University Hospital, Gentofte, Copenhagen

Locations

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Center for Diabetesresearch

Hellerup, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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H-17007893

Identifier Type: -

Identifier Source: org_study_id

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