Effects of Low Versus High Carbohydrate Diet During Rehabilitation on Cardiovascular Function and Metabolism in Type 2 Diabetes
Recruitment status was Active, not recruiting
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Purpose
Compared to the traditional low fat diet for overweight patients with type 2 diabetes, recent evidence shows that low carbohydrate/high protein diets lower triglycerides and postprandial glucose levels more effectively. However, it is not known, whether this diet can also improve the subclinically impaired myocardial function in type 2 diabetes. This prospective parallel group and cross over design study compares the effects of a low glycemic and insulinemic diet (LOGI®) with an isocaloric traditional low fat diet during a three weeks rehabilitation programme with aerobic exercise for overweight type 2 diabetes patients testing the hypothesis, that the low carbohydrate diet improves myocardial function and insulin resistance.
| Condition | Intervention |
|---|---|
|
Type 2 Diabetes Mellitus Overweight |
Other: LOGI diet Other: Low Fat diet |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Single Blind (Investigator) Primary Purpose: Treatment |
| Official Title: | Improvement of Myocardial Function and Metabolic Syndrome in Type 2 Diabetes Patients by a Low Glycemic and Insulinemic Diet (LOGI®) Compared to the Traditional Low Fat Diet - a Prospective Parallel Group/Cross Over Study |
- myocardial diastolic function [ Time Frame: 2-3 weeks treatment period ] [ Designated as safety issue: No ]
- triglycerides, insulin resistance [ Time Frame: 2-3 weeks treatment period ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 41 |
| Study Start Date: | February 2008 |
| Estimated Study Completion Date: | February 2010 |
| Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: LOGI diet
diet based on 25% low glycemic index carbohydrates, 30% protein and 45% fat combined with heart rate controlled, aerobic exercise
|
Other: LOGI diet
diet based on 25% low glycemic index carbohydrates, 30% protein and 45% fat combined with heart rate controlled aerobic exercise for three weeks
|
|
Active Comparator: Low Fat diet
cross over design of three weeks Low Fat diet followed by two weeks LOGI diet always combined with heart rate controlled aerobic exercise
|
Other: Low Fat diet
traditional low fat diet based on 55% mixed glycemic index carbohydrates, 20% protein and 25% fat for three weeks followed by LOGI diet for two weeks, always combined with heart rate controlled aerobic exercise
|
Detailed Description:
This is a single center, short term therapy controlled and prospective study with blinded analyses of the ultrasound data in 41 patients with type 2 diabetes either on dietary control or oral antidiabetic medication. After recruitment and informed consent, patients are randomized to two treatment arms matched for age and concomittant antidiabetic and cardiovascular medication In one treatment arm, the diet is based on the LOGI components: 25% low glycemic index carbohydrates, 30% protein, 45% fat, taken for 3 weeks combined with aerobic exercise, while in the other treatment arm, the isocaloric traditional low fat diet is based on 55% mixed glycemic index carbohydrates, 20 % protein and 25% fat taken for three weeks and combined with the same aerobic exercise protocoll but followed by a two weeks period with LOGI diet and maintained exercise. In both treatment arms, antidiabetic and antihypertensive medication are maintained and/or adapted as necessary and recorded.
All patients receive life style instructions and are updated in their skills of measuring quantity of foods and designing diet plans based on food groups. Laboratory, clinical and ultrasound investigations are performed before and at the end of the three weeks programme and, in the cross over group, also at the end of the subsequent diet programme.
Eligibility| Ages Eligible for Study: | 30 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- type 2 diabetes
- oral antidiabetic medication or dietary control
- overweight
Exclusion Criteria:
- coronary artery disease
Contacts and Locations| Germany | |
| Staedt. Klinikum Muenchen-Bogenhausen | |
| Munich, Bavaria, Germany, 81925 | |
| Principal Investigator: | Helene von Bibra, MD, PhD | Munich Academic Teaching Hospital Bogenhausen |
More Information
Publications:
| Responsible Party: | Prof. Dr. Helene von Bibra, Munich Municipal Hospital |
| ClinicalTrials.gov Identifier: | NCT01004757 History of Changes |
| Other Study ID Numbers: | LOGILoFaReha |
| Study First Received: | October 29, 2009 |
| Last Updated: | October 29, 2009 |
| Health Authority: | Germany: Competence-Center-Quality-Management of the Staedt. Klinikum Muenchen GmbH |
Keywords provided by Munich Municipal Hospital:
|
diastolic function postmeal glucose insulin resistance low carb diet type 2 diabetes |
Additional relevant MeSH terms:
|
Diabetes Mellitus Diabetes Mellitus, Type 2 Overweight Glucose Metabolism Disorders |
Metabolic Diseases Endocrine System Diseases Body Weight Signs and Symptoms |
ClinicalTrials.gov processed this record on June 13, 2013