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

October 29, 2009 updated by: Munich Municipal Hospital

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

41

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Bavaria
      • Munich, Bavaria, Germany, 81925
        • Staedt. Klinikum Muenchen-Bogenhausen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • coronary artery disease

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
myocardial diastolic function
Time Frame: 2-3 weeks treatment period
2-3 weeks treatment period

Secondary Outcome Measures

Outcome Measure
Time Frame
triglycerides, insulin resistance
Time Frame: 2-3 weeks treatment period
2-3 weeks treatment period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Munich Municipal Hospital

Collaborators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2008

Primary Completion (ANTICIPATED)

December 1, 2009

Study Completion (ANTICIPATED)

February 1, 2010

Study Registration Dates

First Submitted

October 29, 2009

First Submitted That Met QC Criteria

October 29, 2009

First Posted (ESTIMATE)

October 30, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

October 30, 2009

Last Update Submitted That Met QC Criteria

October 29, 2009

Last Verified

October 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LOGILoFaReha

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Overweight

Clinical Trials on LOGI diet

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Ethiopia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe