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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03241303
Other study ID # H-17007893
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date August 1, 2017
Est. completion date January 1, 2018

Study information

Verified date March 2020
Source University Hospital, Gentofte, Copenhagen
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


Description:

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.


Recruitment information / eligibility

Status Completed
Enrollment 15
Est. completion date January 1, 2018
Est. primary completion date January 1, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Acarbose
Glucobay tablets on experimental day.
Placebo Oral Tablet
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.
Placebo Saline
9 mg/ml placebo saline infusion on experimental day.

Locations

Country Name City State
Denmark Center for Diabetesresearch Hellerup

Sponsors (2)

Lead Sponsor Collaborator
University Hospital, Gentofte, Copenhagen University of Copenhagen

Country where clinical trial is conducted

Denmark, 

Outcome

Type Measure Description Time frame Safety issue
Primary Plasma glucose The primary outcome is the difference between the effect of increased carbohydrate content in the distal part of the small intestine (obtained by inhibiting alpha-glucosidase with acarbose) on postprandial glucose tolerance (as assessed by area under curve (AUC) for plasma glucose during a standardised liquid mixed meal test) with and without blockade of GLP-1 signalling by exendin(9-39). 240 min
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