Effects of Low Versus High Carbohydrate Diet During Rehabilitation on Cardiovascular Function and Metabolism in Type 2 Diabetes

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2009 by Munich Municipal Hospital.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborators:
Stately Pension System (LVA) Baden-Wuertemberg
Ueberruh Rehabilitation Clinic, Isny, Baden-Wuertemberg
Information provided by:
Munich Municipal Hospital
ClinicalTrials.gov Identifier:
NCT01004757
First received: October 29, 2009
Last updated: NA
Last verified: October 2009
History: No changes posted
  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

Resource links provided by NLM:


Further study details as provided by Munich Municipal Hospital:

Primary Outcome Measures:
  • myocardial diastolic function [ Time Frame: 2-3 weeks treatment period ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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
Criteria

Inclusion Criteria:

  • type 2 diabetes
  • oral antidiabetic medication or dietary control
  • overweight

Exclusion Criteria:

  • coronary artery disease
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01004757

Locations
Germany
Staedt. Klinikum Muenchen-Bogenhausen
Munich, Bavaria, Germany, 81925
Sponsors and Collaborators
Munich Municipal Hospital
Stately Pension System (LVA) Baden-Wuertemberg
Ueberruh Rehabilitation Clinic, Isny, Baden-Wuertemberg
Investigators
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 September 14, 2014