Macronutrients and Gut Hormone Secretion

Type 2 Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01366794
• Other study ID #: 005
• Status: Completed
• Phase: N/A
• First received: May 31, 2011
• Last updated: March 14, 2014
• Start date: September 2011
• Est. completion date: September 2013

Study information

• Verified date: March 2014
• Source: Lund University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Medical Products Agency
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: September 2013
• Est. primary completion date: December 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 35 Years to 70 Years

Eligibility

Inclusion Criteria:

• Healthy status or type 2 diabetes with dietary regulation

Exclusion Criteria:

• Liver disease

• kidney disease

• thyroid disease

Study Design

Allocation: Non-Randomized, Intervention Model: Factorial Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

Other:
• Macronutrients
Glucose 330 kcal Protein 110 kcal Fat emulsion 110 kcal Mixed meal 550 kcal

Locations

Country	Name	City	State
Sweden	Department of Clinical Sciences Lund, Lund University	Lund
Sweden	Lund University	Lund

Sponsors (1)

Lead Sponsor	Collaborator
Lund University

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Release of gut hormones		300 min	No
Secondary	Insulin secretion		300 min	No