Delineation of the Role of Glucagon-like Peptide-1 Signalling in Relation to Increased Carbohydra… (NCT03241303) | Clinical Trial Compass
CompletedNot Applicable
Delineation of the Role of Glucagon-like Peptide-1 Signalling in Relation to Increased Carbohydrate Content in the Distal Small Intestines
Denmark15 participantsStarted 2017-08-01
Plain-language 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
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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