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

Low carbohydrate nutrition in the treatment of type 2 diabetes: A randomized controlled trial on the glycemic effects of a low carbohydrate diet in comparison to a diet upon the recommendations of the clinical practice guideline (high-carb, low-fat)

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN68494994

Enrollment

164

Registered

2011-09-19

Start date

2011-03-22

Completion date

Unknown

Last updated

2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

1. Written consent of patient is required for participation in the trial. The potential study population recruits itself from the group of newly arrived inpatients of a German rehab hospital (indicati

Eligibility

Sex/Gender

All

Inclusion criteria

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

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)

Design outcomes

Primary

Measure	Time frame
1. Blood glucose parameters: 1.1. HbA1c 1.2. Fasting blood glucose Measured at t1: baseline, t2: after 3 weeks, t3: after 24 weeks	—

Secondary

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

Measure

Time frame

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

—

Countries

Germany

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026