Health Condition 1: E119- Type 2 diabetes mellitus without complications
Conditions
Interventions
Intervention1: Magnesium (250 mg) and Vitamin D (600IU) tablet: Oral administration of 1 tablet after breakfast for 90 days.
Control Intervention1: Not Applicable: Not Applicable
Control Intervention2
Sponsors
Pharmed Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Participants of either sex aged between 18 to 70 years. 2. Participants diagnosed with type 2 diabetes having HbA1c >6.5% who are on any antidiabetic drugs (mono or poly OHA) 3. Willing to participate and able to provide signed informed consent. 4. Having BMI between 23 to 40 kg/m2.
Exclusion criteria
Exclusion criteria: 1. Type 1 diabetes or T2DM subject on insulin treatment/and any other supplement for glucose control. 2.Subjects those who in addition to OHA (single or poly, take any herbal/Ayurvedic or home remedies as add on to their OHA. 3. Subjects suffering from complications of diabetes such as diabetic neuropathy, nephropathy, retinopathy, etc. that require urgent treatment. 4. Subjects with uncontrolled hypertension (with or without medication >140/90 mmHg after 5 min of rest). 5. Subjects with an established diagnosis of coronary artery disease (CAD) requiring any medical procedure in the next 6 months, such as angioplasty or bypass surgery; or subjects with New York Heart Association (NYHA) classification III and IV, cardiac insufficiency, or any other clinically significant cardiovascular disease. 6. Subjects with concurrent hepatic dysfunction (defined as AST and/or ALT > 2 times the upper limit of normal) or renal dysfunction (defined as S. creatinine > greater than the upper limit of normal), uncontrolled pulmonary dysfunction (asthmatics and COPD patients). 7. Pregnant/lactating women and women of childbearing potential who do not agree to remain abstinent or use appropriate contraception during the treatment period and for 4 weeks after the end of study treatment. 8. Active user of systemic or oral steroids, oral contraceptive pills, or estrogen replacement therapy. 9. Subjects already taking Mg or Vit-D supplements since preceding one month. 10. Subjects who have a recent or currently known history of alcohol or drug abuse. 11. Subjects with a current or past history of malignancy (any history of malignancy in the past five years). 12. Subjects suffering from major systemic diseases requiring long-term pharmacological treatment (e.g., rheumatoid arthritis, psychological, neurological, endocrine disorders, etc.). 13. Subjects who have completed their participation in any other clinical trial within the last three months. 14. Any other condition that the investigator believes may jeopardize the results of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| a. Change in the dose of OHA(s) over a period of three months. Mean change from baseline in the dose of OHA(s) at the end of the study will be estimated. b. Mean percent change from baseline in Fasting and Postprandial plasma glucose levels at the end of the study. Fasting and Postprandial plasma glucose levels will be estimated to assess the effect of Mg + Vit-D supplements on the serum glucose levels of the participants over study periods.Timepoint: Day 3 to Day 90 | — |
Secondary
| Measure | Time frame |
|---|---|
| a. Mean percent change in Glycosylated Hemoglobin (HbA1c) over a period of three months. Mean change from baseline in HbA1c % at the end of the study will be estimated. b. Mean change in serum insulin levels over a period of three months. c. Mean change on Homeostasis Model Assessment-insulin resistance (HOMA-IR) from baseline to end of the study. d. Change in the SF-36 (RAND) Health Survey scores that measures eight multi-item dimensions of health from baseline to end of the study. e. Change in the Diabetes Symptoms Checklist (DSC) score from baseline to end of the study (day 90). f. Change from baseline to end of the study in waist circumference, body weight, BMI. Estimated mean change from baseline to end of the study in waist circumference, body weight, BMI will be evaluated. g. Change in serum levels of Mg, Vit-D from baseline to end of the study. h. Assessment of the number of treatment-emergent adverse events (AEs) during the on-treatment observation period.Timepoint: Day 3 to Day 90 | — |
Countries
India
Contacts
Public ContactMr Hasan Ali Ahmed
Xplora Clinical Research Services Pvt. Ltd.
Outcome results
None listed