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

This study is currently recruiting participants.
Verified August 2017 by Niels Bjørn Dalsgaard, University Hospital, Gentofte, Copenhagen
Sponsor:
ClinicalTrials.gov Identifier:
NCT03241303
First Posted: August 7, 2017
Last Update Posted: August 8, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
University of Copenhagen
Information provided by (Responsible Party):
Niels Bjørn Dalsgaard, University Hospital, Gentofte, Copenhagen
  Purpose
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

Condition Intervention
Glucose Metabolism Disorders Drug: Acarbose Drug: Placebo Oral Tablet Drug: Exendin (9-39) Drug: Placebo Saline

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official 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

Resource links provided by NLM:


Further study details as provided by Niels Bjørn Dalsgaard, University Hospital, Gentofte, Copenhagen:

Primary Outcome Measures:
  • 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).


Estimated Enrollment: 15
Actual Study Start Date: August 1, 2017
Estimated Study Completion Date: July 1, 2018
Estimated Primary Completion Date: December 1, 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Acarbose
50 mg and 100 mg glucobay tablets. 2 weeks. Other name: Precose
Drug: Acarbose
Glucobay tablets on experimental day.
Other Name: Glucobay, Precose
Placebo Comparator: Placebo Oral tablets
180 mg. 2 weeks.
Drug: Placebo Oral Tablet
Placebo tablets on experimental day.
Experimental: Exendin (9-39)
Infusion of GLP-1 receptor antagonist as a study tool to block GLP-1 activity on experimental day.
Drug: Exendin (9-39)
Infusion of GLP-1 receptor antagonist as a study tool to block GLP-1 activity on experimental day.
Other Name: Ex(9-39)
Placebo Comparator: Placbo Saline
9 mg/ml placebo saline infusion on experimental day.
Drug: Placebo Saline
9 mg/ml placebo saline infusion on experimental day.

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 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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03241303


Contacts
Contact: Niels B Dalsgaard, BSc 60148753 niels.bjoern.dalsgaard@regionh.dk
Contact: Filip K Knop, MD, PhD 26830161 filipknop@dadlnet.dk

Locations
Denmark
Center for Diabetesresearch Recruiting
Hellerup, Denmark, 2900
Contact: Filip K Knop, MD, PhD    26830161    Filipknop@dadlnet.dk   
Sponsors and Collaborators
University Hospital, Gentofte, Copenhagen
University of Copenhagen
Investigators
Study Director: Filip K Knop, MD, PhD University Hospital, Gentofte, Copenhagen
  More Information

Responsible Party: Niels Bjørn Dalsgaard, Bachelor of Science, University Hospital, Gentofte, Copenhagen
ClinicalTrials.gov Identifier: NCT03241303     History of Changes
Other Study ID Numbers: H-17007893
First Submitted: August 2, 2017
First Posted: August 7, 2017
Last Update Posted: August 8, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Niels Bjørn Dalsgaard, University Hospital, Gentofte, Copenhagen:
Glp-1
alpha-glucosidase inhibitor
acarbose

Additional relevant MeSH terms:
Metabolic Diseases
Glucose Metabolism Disorders
Glucagon
Glucagon-Like Peptide 1
Acarbose
Gastrointestinal Agents
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Glycoside Hydrolase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Hypoglycemic Agents
Incretins