Type 2 diabetes mellitus Nutritional, Metabolic, Endocrine Non-insulin-dependent diabetes mellitus
Conditions
Interventions
At each visit, patients will receive the oil for their consumption over 3 months. In both of the groups every 3 months, a visit will be made to provide a customised dietetic intervention. The amount o
Sponsors
Andalusian Regional Ministry of Health (Consejería de Salud de la Junta de Andalucía) (Spain)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Current information as of 09/11/09: 1. Men or women with an age range between 30 and 80 years 2. Body mass index = 25 kg/m^2 and < 40 kg/m^2 3. Acceptance to participate in the study and signed the corresponding informed consent Initial information at time of registration: 1. Men or women with an age range between 30 and 80 years 2. Body mass index = 25 kg/m^2 3. Acceptance to participate in the study and signed the corresponding informed consent
Exclusion criteria
Exclusion criteria: Current information as of 09/11/09: 1. Diabetes at the time of admission to the study: 1.1. Glycaemia baseline = 126 mg/dl or glycaemia 2 hours after the oral overload 1.2. 75 g of glucose = 200 mg/dl 1.3. Diabetes confirmed by a physician and confirmed by other clinical data 1.4. In antidiabetic treatment (oral and/or insulin) 2. Alcohol dependence syndrome or any other addiction 3. Physical, mental or intellectual limitation to take part in a study of dietary intervention 4. Difficulty or lack of predisposition to change food habits 5. Drugs or medical conditions that interfere with the diagnosis of diabetes: 5.1. Beta-blockers 5.2. Systemic glucocorticoids 5.3. Selective inhibitors of the reuptake of serotonin at doses indicated for weight reduction 5.4. Other drugs for weight reduction (orlistat and sibutramine) 5.5. Thyroid Disease suboptimal treatment 5.6. Other endocrine diseases (such as Cushing's disease, acromegaly) 5.7. Fasting triglycerides > 600 mg/dl despite treatment 6. Conditions or circumstances which may affect the conduct of the trial: 6.1. Inability to communicate with the researchers conducting the intervention 6.2. Not willing to accept the treatment assigned by randomisation 6.3. Participation in another project that could interfere with this project 6.4. Loss of weight for any reason superior to 10 % in the last three months, except postpartum 6.5. Inability to walk 400 meters in 10 minutes without stopping 7. Cancer in the last 5 years that needed treatment, unless the prognosis is good 8. Systolic blood pressure = 180 mmHg and/or diastolic blood pressure = 110 mmHg 9. Pregnant women of childbearing age, if: 9.1. Currently pregnant or within 3 months postpartum 9.2. Lactating 9.3. Pregnancy planned during the study period Initial information at time of registration 1. Diabetes at the time of admission to the study: 1.1. Glycaemia baseline = 126 mg/dl or glycaemia 2 hours after the oral overload 1.2. 75 g of glucose = 200 mg/dl 1.3. Diabetes confirmed by a physician and confirmed by other clinical data 1.4. In antidiabetic treatment (oral and/or insulin) 2. Alcohol dependence syndrome or any other addiction 3. Physical, mental or intellectual limitation to take part in a study of dietary intervention 4. Difficulty or lack of predisposition to change food habits 5. Drugs or medical conditions that interfere with the diagnosis of diabetes: 5.1. Thiazide diuretics 5.2. Beta-blockers 5.3. Systemic glucocorticoids 5.4. Selective inhibitors of the reuptake of serotonin at doses indicated for weight reduction 5.5. Other drugs for weight reduction (orlistat and sibutramine) 5.6. Thyroid Disease suboptimal treatment 5.7. Other endocrine diseases (such as Cushing's disease, acromegaly)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of diabetes, diagnosed according to basal blood glucose or oral glucose overload, conducted every 6 months or 12 months respectively after entry into the study, according to recent criteria of the American Diabetes Association (ADA) (a fasting plasma glucose = 126 mg/dl or symptoms of hyperglycaemia and casual plasma glucose = 200 mg/dl or a plasma glucose value at 2 hours after an oral overload of 75 g of glucose = 200 mg/dl. In the absence of unequivocal hyperglycaemia, these criteria should be confirmed by repeating the test on a different day.) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Body mass index (BMI = weight in kilograms divided by the square of height in metres) measured at baseline 2. Waist circumference (abdominal perimeter in cm) 3. Systolic blood pressure (SBP) and diastolic blood pressure (DBP) 4. Pulse pressure (SBP - DBP) 5. Lipid profile: 5.1. Total cholesterol (mg/dl) 5.2. Triglycerides (mg/dl) 5.3. High density lipoprotein (HDL) cholesterol (mg/dl) 5.4. Low density lipoprotein (LDL) cholesterol (mg/dl) 6. Fasting plasma glucose (mg/dl) 7. Insulin (IU/ml) 8. HOMA index (Homeostasis Model Assessment): uU/ml x mmol/L/22.5 (HOMA =[glucose (millimoles per litre) x insulin (microunits per millilitre)]/22.5) was used as a measure of insulin resistance (IR) 9. Haemoglobin A1c (HbA1c) (%) 10. Plasma glucose at 2 hours after oral glucose overload (75 g) measured at months 12 and 24 (and at baseline where applicable) Added 09/11/09: 11. Personal interview (PI) carried out at baseline and months 3, 6, 9, 12, 15, 18, 21 and 24 to assess: 11.1. hypocaloric diet 11.2. physical exercise habits 11.3. toxic habits 12. Assessment of Compliance (AC) at months 3, 6, 9, 12, 15, 18, 21 and 24 Physical Examination (PE) (pts. 2-4 above) measured at baseline, months 3, 6, 9, 12, 15, 18, 21, and 24. Laboratory variables monitored (LVM) (pts. 5-9 above) measured at baseline, months 6, 12, 18 and 24. | — |
Countries
Spain
Outcome results
None listed