- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01034618
Protein Hydrolyzation and Glycemic Control
December 16, 2009 updated by: Maastricht University Medical Center
The Additional Effects of Protein Hydrolysate Supplementation on Glucose Homeostasis in Type 2 Diabetes
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
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
-
-
Limburg
-
Maastricht, Limburg, Netherlands, 6229ER
- Maastricht University Medical Center+
-
-
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
40 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
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)
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
- Primary Purpose: Basic Science
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo
|
|
Experimental: Intact protein
|
|
Experimental: Protein hydrolysate
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
Glucose and insulin homeostasis.
|
Secondary Outcome Measures
Outcome Measure |
---|
Plasma amino acid profiles
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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
December 1, 2007
Primary Completion (Actual)
October 1, 2008
Study Completion (Actual)
April 1, 2009
Study Registration Dates
First Submitted
December 16, 2009
First Submitted That Met QC Criteria
December 16, 2009
First Posted (Estimate)
December 17, 2009
Study Record Updates
Last Update Posted (Estimate)
December 17, 2009
Last Update Submitted That Met QC Criteria
December 16, 2009
Last Verified
December 1, 2009
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 06-3-081
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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