Protein Hydrolyzation and Glycemic Control

This study has been completed.

Sponsor:

Information provided by:

Maastricht University Medical Center

ClinicalTrials.gov Identifier:

NCT01034618

First received: December 16, 2009

Last updated: NA

Last verified: December 2009

History: No changes posted

Tracking Information
First Received Date ^ICMJE	December 16, 2009
Last Updated Date	December 16, 2009
Start Date ^ICMJE	December 2007
Primary Completion Date	October 2008 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: December 16, 2009)	Glucose and insulin homeostasis. [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	No Changes Posted
Current Secondary Outcome Measures ^ICMJE (submitted: December 16, 2009)	Plasma amino acid profiles [ Designated as safety issue: No ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Protein Hydrolyzation and Glycemic Control
Official Title ^ICMJE	The Additional Effects of Protein Hydrolysate Supplementation on Glucose Homeostasis in Type 2 Diabetes
Brief Summary	The insulinotropic effects of protein hydrolysate/amino acid ingestion have been shown to regulate blood glucose homeostasis in both type 2 diabetes patients and normoglycemic controls. The objective of the study is to investigate the optimal dose of such an insulinotropic mixture.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Not Provided
Study Design ^ICMJE	Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Basic Science
Condition ^ICMJE	Diabetes
Intervention ^ICMJE	Dietary Supplement: Protein hydrolyzation
Study Arm (s)	Placebo Comparator: Placebo Intervention: Dietary Supplement: Protein hydrolyzation Experimental: Intact protein Intervention: Dietary Supplement: Protein hydrolyzation Experimental: Protein hydrolysate Intervention: Dietary Supplement: Protein hydrolyzation
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	Not Provided
Completion Date	April 2009
Primary Completion Date	October 2008 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: Male Age between 40 and 70 years Oral blood glucose lowering medication BMI < 35 kg/m2 Exclusion Criteria: Exogenous insulin use Cardiac disease (any cardiac event in the last 5 years) Diabetic complications (microvascular complications, microalbuminuria: albumin:creatinine ratio >2,5)
Gender	Male
Ages	40 Years to 70 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Netherlands

Administrative Information
NCT Number ^ICMJE	NCT01034618
Other Study ID Numbers ^ICMJE	06-3-081
Has Data Monitoring Committee	No
Responsible Party	Ralph J.F. Manders, PhD, Maastricht University Medical Center
Study Sponsor ^ICMJE	Maastricht University Medical Center
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Maastricht University Medical Center
Verification Date	December 2009
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

To Top