Comparison of the effects of a low carbohydrate diet versus a diet upon the recommendations of the clinical practice guideline (high-carb, low-fat) in the treatment of type 2 diabetes

Completed

Conditions: Type 2 diabetes
Nutritional, Metabolic, Endocrine
Non-insulin-dependent diabetes mellitus

Registration Number: ISRCTN68494994

Lead Sponsor: Association for the Advancement of Rehabilitation Research, Norderney (Germany)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 164

Inclusion Criteria

1. Newly arrived inpatient of a selected rehab clinic (indications: cardiology, orthopedic) in North Rhine-Westphalia, Germany
2. Pre-diagnosed type 2 diabetes
3. Age of 18 years and above, either sex
4. Written consent

Exclusion Criteria

1. No type 2 diabetes
2. Renal insufficiency (creatinine of 2.5 mg/dl and above)
3. Pregnancy
4. Consuming disease
5. Rudimental / poor literacy (German)

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Blood glucose parameters: <br>1.1. HbA1c<br>1.2. Fasting blood glucose<br>Measured at t1: baseline, t2: after 3 weeks, t3: after 24 weeks

Secondary Outcome Measures

Name	Time	Method
Surrogate markers:<br>1. Insulin level <br>2. Homeostasis Model of Assessment - Insulin Resistance (HOMA-IR)<br>3. Creatinine<br>4. Glomerular filtration rate<br>5. Body weight<br>6. Body-mass-index<br>7. Waist circumference<br>8. Serum lipid levels [total-, high density lipoprotein (HDL)-, low density lipoprotein (LDL)-cholesterol, triglyceride]<br><br>Survey data: <br>1. Diabetes-medication (type and dose rate)<br>2. Diabetes treatment satisfaction (DTSQs/DTSQc) <br>3. Satisfaction with the diet (self constructed)<br>4. Quality of life (WHO-5)<br>5. Physical activity* (inpatient rehab data [t2], Freiburger Fragebogen zur körperlichen Aktivität [t3])<br><br>*Note: No measurement at time point 1 [t1] due to reduction of activities in rehab-inpatients affected by cardiac or orthopedic events.