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Macronutrients and Gut Hormone Secretion

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01366794
First Posted: June 6, 2011
Last Update Posted: March 17, 2014
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. Read our disclaimer for details.
Information provided by (Responsible Party):
Bo Ahren, Lund University
  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: None (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 Bo Ahren, Lund University:

Primary Outcome Measures:
  • Release of gut hormones [ Time Frame: 300 min ]

Secondary Outcome Measures:
  • Insulin secretion [ Time Frame: 300 min ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
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): 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

Responsible Party: Bo Ahren, Professor, Lund University
ClinicalTrials.gov Identifier: NCT01366794     History of Changes
Other Study ID Numbers: 005
First Submitted: May 31, 2011
First Posted: June 6, 2011
Last Update Posted: March 17, 2014
Last Verified: March 2014

Keywords provided by Bo Ahren, Lund University:
Gut hormones
Insulin secretion

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