Text Size

Macronutrients and Gut Hormone Secretion

This study is currently recruiting participants.
Verified October 2012 by Lund University
Sponsor:
Information provided by (Responsible Party):
Bo Ahren, Lund University
ClinicalTrials.gov Identifier:
NCT01366794
First received: May 31, 2011
Last updated: October 9, 2012
Last verified: October 2012
History of Changes
  Purpose

Study hypothesis is to examine the relative contribution of macronutrients for gut hormone secretion after a mixed meal in healthy volunteers and in subjects with type 2 diabetes. Individual macronutrients or a mixed meal will therefore be served and gut hormones are measured during the following 300 min.


Condition Intervention
Type 2 Diabetes
 Other: Macronutrients

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Factorial Assignment
Masking: Open Label
Official Title: Effects of Macronutrients on Gut Hormone and Islet Hormone Secretion in Healthy Volunteers and Type 2 Diabetes

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Lund University:

Primary Outcome Measures:
  • Release of gut hormones [ Time Frame: 300 min ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Insulin secretion [ Time Frame: 300 min ] [ Designated as safety issue: No ]

Estimated Enrollment: 36
Study Start Date: September 2011
Estimated Study Completion Date: March 2013
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Type 2 diabetes
Administration of macronutrients in type 2 diabetes
 Other: Macronutrients
Glucose 330 kcal Protein 110 kcal Fat emulsion 110 kcal Mixed meal 550 kcal
Other Names:
  • Glucose
  • Protein mixture
  • Fat emulsion
  • Mixed meal
Experimental: Healthy volunteers
Administration of macronutrients in healthy volunteers
 Other: Macronutrients
Glucose 330 kcal Protein 110 kcal Fat emulsion 110 kcal Mixed meal 550 kcal
Other Names:
  • Glucose
  • Protein mixture
  • Fat emulsion
  • Mixed meal

Detailed Description:

In healthy volunteers and subjects with dietary regulated diabetes mellitus, glucose, protein mixture or fat emulsion will be served individually and on a separate occasions a mixed meal will be served. Samples will be taken during the following 300 min. Concentrations of the gut hormones glucose-dependent insulinotropic polypeptide and glucagon-like peptide-1, insulin and glucagon will be determined.

  Eligibility

Ages Eligible for Study:   35 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy status or type 2 diabetes with dietary regulation

Exclusion Criteria:

  • Liver disease
  • kidney disease
  • thyroid disease
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01366794

Locations
Sweden
Department of Clinical Sciences Lund, Lund University Not yet recruiting
Lund, Sweden, 221 84
Contact: Bo Ahrén, PhD     46462220758     Bo.Ahren@med.lu.se    
Principal Investigator: Bo Ahrén, PhD            
Lund University Recruiting
Lund, Sweden, 22184
Contact: Bo Ahrén, MD     +46462220758     Bo.Ahren@med.lu.se    
Principal Investigator: Bo Ahrén, MD            
Sponsors and Collaborators
Lund University
Investigators
Principal Investigator: Bo Ahrén, PhD Lund University
  More Information

No publications provided

Responsible Party: Bo Ahren, Professor, Lund University
ClinicalTrials.gov Identifier: NCT01366794     History of Changes
Other Study ID Numbers: 005
Study First Received: May 31, 2011
Last Updated: October 9, 2012
Health Authority: Sweden: Medical Products Agency

Keywords provided by Lund University:
Gut hormones
Insulin secretion

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
 Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 22, 2013