Protein Hydrolyzation and Glycemic Control | NCT01034618

Studies
Protein Hydrolyzation and Glycemic Control

NCT01034618

Sponsor

Maastricht University Medical Center

Status

Completed

Last Update Posted

Dec 17, 2009Estimated

Enrollment

Not provided

Phase

Not Applicable

Conditions

Diabetes

Interventions

Protein hydrolyzation

Countries

Netherlands

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2007

Primary Completion Date

Oct 2008Actual

Completion Date

Apr 2009Actual

First Submitted Date

Dec 16, 2009

First Submission Date that Met QC Criteria

Dec 16, 2009

First Posted Date

Dec 17, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 16, 2009

Last Update Posted Date

Dec 17, 2009Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

Not provided

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
Placebo	Placebo Comparator	Dietary Supplement: Protein hydrolyzation
Intact protein	Experimental	Dietary Supplement: Protein hydrolyzation
Protein hydrolysate	Experimental	Dietary Supplement: Protein hydrolyzation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Protein hydrolyzation	Dietary Supplement		Intact protein Placebo Protein hydrolysate

Measure	Description	Time Frame
Glucose and insulin homeostasis.

Measure	Description	Time Frame
Plasma amino acid profiles

Eligibility Module

Eligibility Criteria

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)

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Maastricht University Medical Center+		Maastricht	Limburg	6229ER	Netherlands

Condition Browse Module

MeSH Terms

ID	Term
D003920	Diabetes Mellitus

Ancestor Terms

ID	Term
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D004700	Endocrine System Diseases

Browse Leaves

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Browse Branches

Not provided