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Macronutrients and Gut Hormone Secretion

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ClinicalTrials.gov Identifier: NCT01366794
Recruitment Status : Completed
First Posted : June 6, 2011
Last Update Posted : March 17, 2014
Sponsor:
Information provided by (Responsible Party):
Bo Ahren, Lund University

Brief Summary:
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 or disease Intervention/treatment Phase
Type 2 Diabetes Other: Macronutrients Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
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
Study Start Date : September 2011
Actual Primary Completion Date : December 2012
Actual Study Completion Date : September 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hormones
U.S. FDA Resources

Arm Intervention/treatment
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



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

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


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

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

Responsible Party: Bo Ahren, Professor, Lund University
ClinicalTrials.gov Identifier: NCT01366794     History of Changes
Other Study ID Numbers: 005
First Posted: June 6, 2011    Key Record Dates
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