Health Condition 1: E116- Type 2 diabetes mellitus with other specified complications
Conditions
Interventions
Intervention1: Metformin 1000 mg: Group B: Participants would
receive Metformin 1000 mg/day
orally in divided doses after meals for 3 months
Control Intervention1: Metformin 500 mg: Group A: Participa
Sponsors
Government Medical College Amritsar
Eligibility
Inclusion criteria
Inclusion criteria: Patients diagnosed with Type 2 DM of age group 45-75 years of any sex as per American Diabetes Association criteria, Patients with confirmed clinical and/or radiographic diagnosis of early Kellgren-Lawrence grade1,2 Osteoarthritis in at least one joint of age group 45-75 years of any sex who fulfils American College of Rheumatology criterion for the diagnosis of OA with evidence of metabolic syndrome, Metformin naive or limited exposure less than 3 months, with 4-week washout period if previously used, to assess dose response, Willing and able to provide written informed consent
Exclusion criteria
Exclusion criteria: Type 1 DM, gestational diabetes, HbA1c less than 6.5 percent or greater than 9.0 percent, Nondiabetics, Patient with inflammatory arthritis e.g., Rheumatoid arthritis, psoriatic, Gout, systemic autoimmune diseases e.g., SLE or other knee pain causes meniscal injury, or patellofemoral syndrome, Radiographically severe knee OA of grade 3, 4 K-L, History of significant joint injury or surgery e.g., total hip/knee Arthroplasty within last 6 months, Current or recent within 3 months use of systemic corticosteroids, weight loss medications, other antidiabetic agents, recent intra articular injections, Use of confounding pain medications e.g., gabapentin, duloxetine, NSAIDs within 4 weeks, Contraindication to metformin i.e. severe renal impairment eGFR less than 30ml per minute per 1.73m2, known hypersensitivity to metformin, severe liver disease SGOT, SGPT greater than 1000 Unit per Litre and SGOT upon SGPT is 2 times greater, history of lactic acidosis, severe hypoxic states e.g., heart failure, respiratory insufficiency, Pregnant or breastfeeding women.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare the efficacy of Metformin in two different doses 500 mg vs. 1000 mg on pain parameters in metabolic knee OA.Timepoint: Baseline,2 weeks,4 weeks,6 weeks 8 weeks,10 weeks,12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess metabolic status of patient.Timepoint: Baseline,2 weeks,4 weeks,6 weeks 8 weeks,10 weeks,12 weeks;To enumerate the reported adverse drug reactions amongst allocated patientsTimepoint: Baseline,2 weeks,4 weeks,6 weeks 8 weeks,10 weeks,12 weeks;To assess quality of life of recruited patientsTimepoint: Baseline,2 weeks,4 weeks,6 weeks 8 weeks,10 weeks,12 weeks | — |
Countries
India
Contacts
Public ContactDr Ramandeep Yadav
Government Medical College Amritsar
Outcome results
None listed