Health Condition 1: E660- Obesity due to excess calories
Conditions
Interventions
Intervention1: Weight reduction: Teneligliptin and Low crb diet physical exercise
Intervention2: Low carbohydrate diet & Physical ecercise: low carbohydrate diet (48 weeks) which Includes:
Natural pro
Sponsors
Self financed
Eligibility
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Reduction of Body weight 10-15 % from the baseline. Improvement of Blood pressure Improvement of Lipid levelsTimepoint: within one year | — |
Secondary
| Measure | Time frame |
|---|---|
| Improvement of weight related commodities such as Improvement of Blood pressure Improvement of Lipid levelsTimepoint: Within one year | — |
Countries
India
Contacts
Public ContactRanakishor Pelluri
SRIHER chennai
Outcome results
None listed