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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00817973
Other study ID # CERN-PPL (5A) LSM
Secondary ID
Status Completed
Phase N/A
First received January 6, 2009
Last updated January 8, 2009

Study information

Verified date January 2009
Source Aarhus University Hospital
Contact n/a
Is FDA regulated No
Health authority Denmark: Ethics Committee
Study type Interventional

Clinical Trial Summary

Enhanced and prolonged postprandial triglyceride responses involve increased cardiovascular risk in type 2 diabetes. It has been demonstrated that dietary fat and carbohydrates profoundly influence postprandial hypertriglyceridemia in type 2 diabetes, whereas little information exists about the effect of proteins.

The purpose of this study is to compare the effects of the proteins casein, whey, cod, and gluten on postprandial lipid and incretin responses to a high-fat meal in type 2 diabetes.


Recruitment information / eligibility

Status Completed
Enrollment 12
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 40 Years to 75 Years
Eligibility Inclusion Criteria:

- Diabetes

Exclusion Criteria:

- Liver, Kidney- and/or Heart Disease

- Serious Hypertension (160/110 mmHg)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Prevention


Intervention

Dietary Supplement:
Casein

Whey

Cod

Gluten


Locations

Country Name City State
Denmark Department of Clinical Nutrition Aarhus

Sponsors (3)

Lead Sponsor Collaborator
Aarhus University Hospital Nordic Centre of Excellence, The Danish Obesity Research Centre

Country where clinical trial is conducted

Denmark, 

Outcome

Type Measure Description Time frame Safety issue
Primary Triglyceride levels 0h- 2h- 4h- 6h- 7h- 8h postprandial No
Secondary Incretin levels 0h- 0.5h- 1h- 2h- 4h- 6h- 8h postprandial No
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