Macronutrients and Gut Hormone Secretion

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bo Ahren, Lund University
ClinicalTrials.gov Identifier:
NCT01366794
First received: May 31, 2011
Last updated: March 14, 2014
Last verified: March 2014
  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:


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
Study Completion Date: September 2013
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01366794

Locations
Sweden
Department of Clinical Sciences Lund, Lund University
Lund, Sweden, 221 84
Lund University
Lund, Sweden, 22184
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: March 14, 2014
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 July 20, 2014