Fat-induced Release of GLP-1 in Humans

Type 2 Diabetes Clinical Trial

Official title:

Short Fatty Acids-induced Release of GLP-1 in Humans

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02264951
• Other study ID #: SFAS
• Status: Completed
• Phase: N/A
• First received: October 9, 2014
• Last updated: October 9, 2014
• Start date: October 2013
• Est. completion date: February 2014

Study information

• Verified date: October 2014
• Source: Glostrup University Hospital, Copenhagen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: National Board of HealthDenmark: The Regional Committee on Biomedical Research EthicsDenmark: Danish Dataprotection Agency
• Study type: Interventional

Clinical Trial Summary

This study compared the incretin-releasing effect of C8-diet oil and tributyrin with that of 20 ml olive oil on a molar basis in human volunteers.

Description:

A structured triglyceride (1,3-di-octanoyl-2-oleoyl-glycerol, called C8-diet oil), which upon digestion results in generation of two medium-chain fatty acids and 2-oleoyl-glycerol (2-OG), may lead to activation of GPR119 only, since medium fatty acids are poor agonists for fatty acid receptors.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: February 2014
• Est. primary completion date: December 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

• Caucasian healthy male subjects

• Body mass index (BMI) 19 to 25 kg/m2

• Informed consent

Exclusion Criteria:

• Anaemia

• Diabetes mellitus

• Gastrointestinal diseases or operations interacting with intestinal absorption

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Type 2 Diabetes

Intervention

Dietary Supplement:
• Tributyrin
a triglyceride containing three C4-acids
• C8-diet oil
a triglyceride containing 2 C8-fatty acids and one oleic acid at sn-2 position
• Olive oil
a triglyceride containing mostly three oleic acids
• Carrot
mainly water and glucose

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Glostrup University Hospital, Copenhagen	University of Copenhagen

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	plasma GLP-1		2 hours postprandial	No
Primary	plasma GIP		2 hours postprandial	No
Secondary	plasma insulin		2 hours postprandial	No
Secondary	plasma PYY		2 hours postprandial	No
Secondary	plasma glucose		2 hours postprandial	No
Secondary	plasma neurotensin		2 hour postprandial	No
Secondary	plasma CCK		2 hour postprandial	No