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

Primary Purpose

Type 2 Diabetes Mellitus, Overweight

Status
Unknown status
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
LOGI diet
Low Fat diet
Sponsored by
Munich Municipal Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 2 Diabetes Mellitus focused on measuring diastolic function, postmeal glucose, insulin resistance, low carb diet, type 2 diabetes

Eligibility Criteria

30 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • coronary artery disease

Sites / Locations

  • Staedt. Klinikum Muenchen-Bogenhausen

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

LOGI diet

Low Fat diet

Arm Description

diet based on 25% low glycemic index carbohydrates, 30% protein and 45% fat combined with heart rate controlled, aerobic exercise

cross over design of three weeks Low Fat diet followed by two weeks LOGI diet always combined with heart rate controlled aerobic exercise

Outcomes

Primary Outcome Measures

myocardial diastolic function

Secondary Outcome Measures

triglycerides, insulin resistance

Full Information

First Posted
October 29, 2009
Last Updated
October 29, 2009
Sponsor
Munich Municipal Hospital
Collaborators
Stately Pension System (LVA) Baden-Wuertemberg, Ueberruh Rehabilitation Clinic, Isny, Baden-Wuertemberg
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1. Study Identification

Unique Protocol Identification Number
NCT01004757
Brief Title
Effects of Low Versus High Carbohydrate Diet During Rehabilitation on Cardiovascular Function and Metabolism in Type 2 Diabetes
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2009
Overall Recruitment Status
Unknown status
Study Start Date
February 2008 (undefined)
Primary Completion Date
December 2009 (Anticipated)
Study Completion Date
February 2010 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Munich Municipal Hospital
Collaborators
Stately Pension System (LVA) Baden-Wuertemberg, Ueberruh Rehabilitation Clinic, Isny, Baden-Wuertemberg

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus, Overweight
Keywords
diastolic function, postmeal glucose, insulin resistance, low carb diet, type 2 diabetes

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
41 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
LOGI diet
Arm Type
Active Comparator
Arm Description
diet based on 25% low glycemic index carbohydrates, 30% protein and 45% fat combined with heart rate controlled, aerobic exercise
Arm Title
Low Fat diet
Arm Type
Active Comparator
Arm Description
cross over design of three weeks Low Fat diet followed by two weeks LOGI diet always combined with heart rate controlled aerobic exercise
Intervention Type
Other
Intervention Name(s)
LOGI diet
Intervention Description
diet based on 25% low glycemic index carbohydrates, 30% protein and 45% fat combined with heart rate controlled aerobic exercise for three weeks
Intervention Type
Other
Intervention Name(s)
Low Fat diet
Intervention Description
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
Primary Outcome Measure Information:
Title
myocardial diastolic function
Time Frame
2-3 weeks treatment period
Secondary Outcome Measure Information:
Title
triglycerides, insulin resistance
Time Frame
2-3 weeks treatment period

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: type 2 diabetes oral antidiabetic medication or dietary control overweight Exclusion Criteria: coronary artery disease
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Helene von Bibra, MD, PhD
Organizational Affiliation
Munich Academic Teaching Hospital Bogenhausen
Official's Role
Principal Investigator
Facility Information:
Facility Name
Staedt. Klinikum Muenchen-Bogenhausen
City
Munich
State/Province
Bavaria
ZIP/Postal Code
81925
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
18700873
Citation
Hession M, Rolland C, Kulkarni U, Wise A, Broom J. Systematic review of randomized controlled trials of low-carbohydrate vs. low-fat/low-calorie diets in the management of obesity and its comorbidities. Obes Rev. 2009 Jan;10(1):36-50. doi: 10.1111/j.1467-789X.2008.00518.x. Epub 2008 Aug 11.
Results Reference
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PubMed Identifier
15331548
Citation
Gannon MC, Nuttall FQ. Effect of a high-protein, low-carbohydrate diet on blood glucose control in people with type 2 diabetes. Diabetes. 2004 Sep;53(9):2375-82. doi: 10.2337/diabetes.53.9.2375.
Results Reference
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PubMed Identifier
17498573
Citation
Yu CM, Sanderson JE, Marwick TH, Oh JK. Tissue Doppler imaging a new prognosticator for cardiovascular diseases. J Am Coll Cardiol. 2007 May 15;49(19):1903-14. doi: 10.1016/j.jacc.2007.01.078. Epub 2007 Apr 30.
Results Reference
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PubMed Identifier
16305069
Citation
Von Bibra H, Thrainsdottir IS, Hansen A, Dounis V, Malmberg K, Ryden L. Tissue Doppler imaging for the detection and quantitation of myocardial dysfunction in patients with type 2 diabetes mellitus. Diab Vasc Dis Res. 2005 Feb;2(1):24-30. doi: 10.3132/dvdr.2005.002.
Results Reference
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PubMed Identifier
15547039
Citation
von Bibra H, Hansen A, Dounis V, Bystedt T, Malmberg K, Ryden L. Augmented metabolic control improves myocardial diastolic function and perfusion in patients with non-insulin dependent diabetes. Heart. 2004 Dec;90(12):1483-4. doi: 10.1136/hrt.2003.020842. No abstract available.
Results Reference
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Effects of Low Versus High Carbohydrate Diet During Rehabilitation on Cardiovascular Function and Metabolism in Type 2 Diabetes

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