Status:
COMPLETED
Nutritional Intervention With Moderately High-protein, Low-glycemic Load Products in Type-2 Diabetes Patients
Lead Sponsor:
Clinica Universidad de Navarra, Universidad de Navarra
Collaborating Sponsors:
Rovi Pharmaceuticals Laboratories
Equipe Enervit
Conditions:
Type-2 Diabetes
Overweight
Eligibility:
All Genders
45-75 years
Phase:
NA
Brief Summary
The main objective of this study is to evaluate the effects on anthropometric, glucose metabolism and lipid profile biomarkers of exchanging with high-protein, low-glycemic index products (40-30-30) t...
Detailed Description
Type 2 diabetes prevalence in adults has grown in the last years in many societies, accompanying the high incidence of obesity-related and other cardiovascular risk factors. Indeed, obesity is the mos...
Eligibility Criteria
Inclusion
- Clinically diagnosed of type-2 Diabetes
- Under dietary treatment or with Metformin
- Body Mass Index (BMI) Between 22 and 35 kg/m2
Exclusion
- BMI under 22 or over 35 kg/m2
- To follow a pharmacological treatment with other drugs but metformin
- To be already insulin-dependent
- To have other concomitant pharmacological treatments for weight loss, hormonal substitutive therapy, altered thyroid function, etc. without an stable dosage (at least three months prior the beginning of the study).
- To suffer from complications due to type 2 diabetes (microangiopathy, polyneuropathy, cardiopathy, hepatic and renal impairments, etc)
- To have a recent (less than 3 months before the beginning of the study) uncontrolled diagnostic of hypercholesterolemia and/or hypertriglyceridemia.
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2010
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT01264523
Start Date
September 1 2009
End Date
September 1 2010
Last Update
September 10 2012
Active Locations (1)
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1
Department of Nutrition, Food Science, Physiology and Toxicology. University of Navarra
Pamplona, Navarre, Spain, 31008