Low-carbohydrate high-protein diet in obese diabetic subjects

Authors
Category Primary study
Registry of TrialsISRCTN registry
Year 2008
INTERVENTION: Patients will be assigned to either the protein sparing modified fast (PSMF) or the Go Lower diet. In both instances, patients will be given oral and written information about the diet. Patients on Go Lower will be given weekly food packs while the patients on PSMF will prepare their own food. Patients will be seen at 2 and 4 weeks post‐randomisation and then monthly for a total of 1 year. CONDITION: Obese, type 2 diabetics ; Nutritional, Metabolic, Endocrine ; Obesity PRIMARY OUTCOME: Weight change, measured in kilograms at baseline, 3, 6, 9 and 23 months. SECONDARY OUTCOME: 1. Changes in cardiovascular risk, measured by looking at total cholesterol, triacylglycerols, high density lipoprotein (HDL), low‐density lipoprotein (LDL), C‐reactive protein (mg/L), fasting glucose (all in mmol/L), fasting insulin (uU/ml), HbA1c (%), waist circumference (cm), blood pressure (mmHg); 2. Glycaemic control will be measured using fasting glucose, fasting insulin and HbA1c; 3. Metabolic rate is being measured using the ventilated hood (Quark RMR machine) from COSMED; 4. Liver function will be assessed by measuring albumin (g/L), total bilirubin (umol/L), alkaline phosphatase, alanine aminotransferase and gamma‐glutamyl transferase (U/L). For kidney function we will measure urea (mmol/L) and creatinine (umol/L) and calculate the estimated glomerular filtration.; 5. Quality of life, measured using the following questionnaires: Weight: Decisional Balance, Orwell 97, Diabetes treatment satisfaction questionnaire, Audit of Diabetes‐Dependent quality of life, Lee fatigue scale, General Practice Physical activity questionnaire, Major (ICD‐10) depression inventory and the Epworth Sleepiness Scale; 6. Changes in adipokines; ; These will all be measured at baseline, 3, 6, 9 and 23 months. INCLUSION CRITERIA: 1. Men and women between 18 and 75 years of age 2. Body Mass Index (BMI) greater than or equal to 30 kg/m^2 3. Poorly controlled type II diabetes mellitus (HbA1c greater than or equal to 7.5%)
Epistemonikos ID: 0ecc92e47668bd4cf6726595d54ad67a075a8a2d
First added on: Aug 21, 2024