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

NCT01004757 | Unknown DMC

• 1 other identifier: LOGILoFaReha
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 2 Diabetes Mellitus; Overweight

Keywords

diastolic function; postmeal glucose; insulin resistance; low carb diet; type 2 diabetes

Outcome Measures

Primary Outcomes (1)

• myocardial diastolic function

  2-3 weeks treatment period

Secondary Outcomes (1)

• triglycerides, insulin resistance

  2-3 weeks treatment period

Study Arms (2)

LOGI diet

ACTIVE COMPARATOR

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

Other: LOGI diet

Low Fat diet

ACTIVE COMPARATOR

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

Interventions

LOGI diet OTHER

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

LOGI diet

Low Fat diet OTHER

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

Low Fat diet

Eligibility Criteria

• Age: 30 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• coronary artery disease

Sponsors & Collaborators

• Munich Municipal Hospital: lead
• Stately Pension System (LVA) Baden-Wuertemberg: collaborator
• Ueberruh Rehabilitation Clinic, Isny, Baden-Wuertemberg: collaborator

Study Sites (1)

Staedt. Klinikum Muenchen-Bogenhausen

Munich, Bavaria, 81925, Germany

Location

Related Publications (5)

• 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.

  PMID: 18700873 BACKGROUND

• 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.

  PMID: 15331548 BACKGROUND

• 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.

  PMID: 17498573 BACKGROUND

• 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.

  PMID: 16305069 BACKGROUND

• 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.

  PMID: 15547039 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Overweight; Insulin Resistance

Interventions

Diet, Fat-Restricted

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Hyperinsulinism

Intervention Hierarchy (Ancestors)

Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Helene von Bibra, MD, PhD

  Munich Academic Teaching Hospital Bogenhausen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 29, 2009
• First Posted: October 30, 2009
• Study Start: February 1, 2008
• Primary Completion: December 1, 2009
• Study Completion: February 1, 2010
• Last Updated: October 30, 2009

Record last verified: 2009-10

Locations

DE (1)