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

Type 2 Diabetes Mellitus Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01004757
• Other study ID #: LOGILoFaReha
• Status: Active, not recruiting
• Phase: N/A
• First received: October 29, 2009
• Last updated: October 29, 2009
• Start date: February 2008
• Est. completion date: February 2010

Study information

• Verified date: October 2009
• Source: Munich Municipal Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Competence-Center-Quality-Management of the Staedt. Klinikum Muenchen GmbH
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 41
• Est. completion date: February 2010
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 70 Years

Eligibility

Inclusion Criteria:

• type 2 diabetes

• oral antidiabetic medication or dietary control

• overweight

Exclusion Criteria:

• coronary artery disease

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Overweight
• Type 2 Diabetes Mellitus

Intervention

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
• 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

Locations

Country	Name	City	State
Germany	Staedt. Klinikum Muenchen-Bogenhausen	Munich	Bavaria

Sponsors (3)

Lead Sponsor	Collaborator
Munich Municipal Hospital	Stately Pension System (LVA) Baden-Wuertemberg, Ueberruh Rehabilitation Clinic, Isny, Baden-Wuertemberg

Country where clinical trial is conducted

Germany, 

References & Publications (5)

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. — View 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. Review. — View Citation

von Bibra H, Hansen A, Dounis V, Bystedt T, Malmberg K, Rydén L. Augmented metabolic control improves myocardial diastolic function and perfusion in patients with non-insulin dependent diabetes. Heart. 2004 Dec;90(12):1483-4. — View Citation

Von Bibra H, Thrainsdottir IS, Hansen A, Dounis V, Malmberg K, Rydén 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. — View 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. Epub 2007 Apr 30. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	myocardial diastolic function		2-3 weeks treatment period	No
Secondary	triglycerides, insulin resistance		2-3 weeks treatment period	No