Low-carbohydrate high-protein diet in obese diabetic subjects

Alterations in the macronutrient content of the diet and effects on body composition, cardiovascular disease risk and the control of energy metabolism in obese patients with type II diabetes mellitus

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN20400186

Enrollment

120

Registered

2008-09-15

Start date

2008-04-15

Completion date

Unknown

Last updated

2016-10-17

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

Conditions

Obese, type 2 diabetics Nutritional, Metabolic, Endocrine Obesity

Interventions

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

Eligibility

Sex/Gender

All

Inclusion criteria

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%)

Exclusion criteria

Exclusion criteria: 1. A history or current renal, hepatic disease or cancer 2. Have had a major coronary event in the last 6 months 3. Diet related diseases 4. On antidepressant or obesity-related pharmacotherapy 5. Current pregnancy or lactating

Design outcomes

Primary

Measure	Time frame
Weight change, measured in kilograms at baseline, 3, 6, 9 and 23 months.	—

Secondary

Measure	Time frame
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.	—

Measure

Time frame

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.

—

Countries

United Kingdom

Outcome results

None listed

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