Status:
COMPLETED
Delineation of the Role of Glucagon-like Peptide-1 Signalling in Relation to Increased Carbohydrate Content in the Distal Small Intestines
Lead Sponsor:
University Hospital, Gentofte, Copenhagen
Collaborating Sponsors:
University of Copenhagen
Conditions:
Glucose Metabolism Disorders
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 patie...
Detailed 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 postp...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2018
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT03241303
Start Date
August 1 2017
End Date
January 1 2018
Last Update
March 26 2020
Active Locations (1)
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1
Center for Diabetesresearch
Hellerup, Denmark, 2900