Study on Obesity management in non diabetics
- Conditions
- Health Condition 1: E660- Obesity due to excess calories
- Registration Number
- CTRI/2020/02/023329
- Lead Sponsor
- Self financed
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Body mass index (BMI) >= 30 kg/m2 or >= 27 kg/m2 with the presence of at least one of the following weight-related comorbidities (treated or untreated):
Mild to Moderate Hypertension
Dyslipidemia
History of at least one self-reported unsuccessful dietary effort to lose body weight
Subjects are excluded from the study if any of the following criteria apply:
1.Glycemic related:
HbA1C >= 48 mmol/mol (6.5%) at screening
Treatment with glucose lowering agent (s) within 90 days before screening
Treatment with a DPP-4 inhibitors or GLP-1 receptor agonists within 180 days of before screening.
2.Obesity related:
A self-reported change in body weight > 5 kg (11 lbs) within 90 days before screening irrespective of medical records
Treatment with any medication for the indication of obesity within the past 90 days before screening
Previous or planned (during the study period) obesity treatment with surgery or a weight loss device. However, the following are allowed:
liposuction and/or abdominoplasty, if performed > 1 year before screening
lap banding, if the band has been removed > 1 year before screening
Intragastric balloon, if the balloon has been removed > 1 year before screening
Duodenal-jejunal bypass sleeve, if the sleeve has been removed > 1 year before screening
Gastrointestinal surgeries that induces mal absorption
Indication of liver diseases (elevated ALT/AST or ALP)
History of pancreatitis
Uncontrolled thyroid disease (TSH > 6.0 mIU/L or < 0.4 mIU/L)
Severe Hypertension
Severe Obstructive sleep apnoea or cardiovascular disease
Psychological related:
History of major depressive disorder within 2 years before screening
Diagnosis of other severe psychiatric disorder (e.g., schizophrenia, bipolar disorder)
A Patient Health Questionnaire-9 (PHQ-9) score of >= 15 at screening
A lifetime history of a suicidal attempt
Suicidal behavior within 30 days before screening
Others:
Pregnant / lactating women
Patients on assistance of use of contraceptive pills
Patients receiving treatment with systemic corticosteroids
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method