Obese type 2 diabetes mellitus patients Nutritional, Metabolic, Endocrine
Conditions
Interventions
The total study duration will be six months, i.e. 2-month recruitment (or selection period) and 4-month follow up.
The study will be divided into two periods:
1. A screening period to identify the su
Sponsors
Pronokal® Group
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients of both sexes aged between the ages of 30 and 65 2. Patients diagnosed with type 2 diabetes mellitus with less than 10 years of evolution, non-insulin- dependent1, with pancreatic ß-cell reserve maintained and GAD-negative 3. Patients with HbA1c =9 4. Patients with a BMI between 30 and 35 5. Informed consent (IC) form signed before study participation
Exclusion criteria
Exclusion criteria: 1. Patients over 65 years 2. Pregnant or breastfeeding patients 3. Patients with severe eating disorders, alcoholism or drug abuse 4. Patients with severe psychological disorders (e.g. schizophrenia, bipolar disorder) 5. Patients with hepatic impairment 6. Patients with renal impairment 7. Patients with type 1 diabetes mellitus or insulin-dependent, or currently in treatment with insulin, or candidates for insulin treatment within a short period of time 8. Patients with obesity caused by other endocrine diseases (except T2DM) 9. Patients with blood disorders 10. Cancer patients 11. Patients with cardiovascular or cerebrovascular diseases (heart rhythm abnormalities, recent myocardial infarction [<6 months], unstable angina, decompensated heart failure, recent cerebrovascular accident [<6 months]) 12. Patients with gout 13. Patients with kidney stones 14. Patients with cholelithiasis 15. Patients with depression 16. Patients with electrolyte abnormalities 17. Patients with orthostatic hypotension 18. Patients with an altered or abnormal electrocardiogram
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the safety and tolerability of a protein diet (PronoKal method) compared to a low-calorie diet (calorie intake 10% below basal metabolic rate, calculated using the FAO/WHO/UN formula21) in obese diabetic patients over a period of four months. This will include measuring: 1. Weight and abdominal circumference 2. Capillary glycaemia and ketonemia 3. Blood pressure 4. Changes in the DM treatment 5. Adverse effects 6. Electrocardiogram 7. Changes in the DM treatment 8. Pancreatic ß-cell reserve maintained | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. To evaluate the differences in weight loss between obese diabetic patients who follow a protein diet (PronoKal method) vs obese diabetic patients who follow a balanced, low-calorie diet 2. To evaluate the effectiveness of the protein diet vs the low-calorie diet on metabolic control in obese diabetic patients 3. To compare the determination of plasma mineral values (sodium, calcium, potassium, magnesium, chlorine) in both groups (patients with a protein diet vs patients with a low-calorie diet), at 4 months of following the diet for reducing weight 4. To evaluate the effect of dietary protein vs a low-calorie diet on cardiovascular risk (CV) between the baseline and final visits 5. To evaluate the effect of a protein diet vs low-calorie diet on the pharmacological requirements for the treatment of DM between baseline and final visits 6. To compare diet adherence in both groups (patients who follow a protein diet vs patients who follow a low-calorie diet) 7. To compare diet satisfaction in both groups (patients who follow a protein diet vs patients who follow a low-calorie diet) | — |
Countries
Spain
Outcome results
None listed