Macronutrients and Gut Hormone Secretion

March 14, 2014 updated by: Bo Ahren, Lund University

Effects of Macronutrients on Gut Hormone and Islet Hormone Secretion in Healthy Volunteers and Type 2 Diabetes

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Anticipated)

36

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Lund, Sweden, 22184
        • Lund University
      • Lund, Sweden, 221 84
        • Department of Clinical Sciences Lund, Lund University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Healthy status or type 2 diabetes with dietary regulation

Exclusion Criteria:

  • Liver disease
  • kidney disease
  • thyroid disease

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Non-Randomized
  • Interventional Model: Factorial Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Release of gut hormones
Time Frame: 300 min
300 min

Secondary Outcome Measures

Outcome Measure
Time Frame
Insulin secretion
Time Frame: 300 min
300 min

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lund University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2011

Primary Completion (Actual)

December 1, 2012

Study Completion (Actual)

September 1, 2013

Study Registration Dates

First Submitted

May 31, 2011

First Submitted That Met QC Criteria

June 2, 2011

First Posted (Estimate)

June 6, 2011

Study Record Updates

Last Update Posted (Estimate)

March 17, 2014

Last Update Submitted That Met QC Criteria

March 14, 2014

Last Verified

March 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 005

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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