Safety of the Pronokal method in obese diabetic patients: The Diaprokal study.

Completed

• Conditions: Obese type 2 diabetes mellitus patients; Nutritional, Metabolic, Endocrine

• Registration Number: ISRCTN55835754
• Lead Sponsor: Pronokal® Group

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-11-28
• Last Update Posted: 6 July 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 90

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified