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Completed

NCT Number: NCT03241303

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

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

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Key information

Conditions

Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Center for Diabetesresearch

Hellerup, 2900, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Acarbose

Drug

Glucobay tablets on experimental day.

Other names: Glucobay, Precose

Placebo oral tablet

Drug

Placebo tablets on experimental day.

Exendin (9-39)

Drug

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

Other names: Ex(9-39)

Placebo saline

Drug

9 mg/ml placebo saline infusion on experimental day.

Primary outcomes

  1. Plasma glucose

    Time frame: 240 min

    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).

Sponsors and collaborators

Lead sponsor

University Hospital, Gentofte, Copenhagen

Other

Collaborators

  • University of Copenhagen

Registry information

Official study title

The Role of Glucagon-like Peptide-1 Receptor Signalling in the Glucose-lowering Effect of Increased Carbohydrate Content in the Distal Small Intestines After Meal Ingestion in Patients With Type 2 Diabetes

Acronym: AlfaEx

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Aug 7, 2017
Registry last updated
Mar 26, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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