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Clinical Trial Details (PDF Generation Date :- Tue, 28 Sep 2021 02:19:39 GMT)

CTRI Number CTRI/2014/01/004319 [Registered on: 16/01/2014] - Trial Registered Retrospectively Last Modified On 24/12/2013 Post Graduate Thesis Yes Type of Trial Interventional Type of Study Nutraceutical Study Design Randomized, Parallel Group, Placebo Controlled Trial Public Title of Study Relation between body selenium, insulin resistance and systemic inflammation in prediabetes and role of selenium supplementation in prevention of diabetes Scientific Title of Serum selenoprotein P and glutathione peroxidase levels in individuals with prediabetes and their Study association with insulin resistance and inflammatory markers Secondary IDs if Any Secondary ID Identifier NIL NIL Details of Principal Details of Principal Investigator Investigator or overall Name Satinath Mukhopadhyay Trial Coordinator (multi-center study) Designation Professor Affiliation IPGMER and SSKM Hospital Calcutta Address Department of and Metabolism Room 9 4th floor Ronald Ross Building IPGMER and SSKM Hospital 244 AJC Bose Road 700020 Phone Fax Email [email protected] Details Contact Details Contact Person (Scientific Query) Person (Scientific Name Deep Dutta Query) Designation DM (Endocrinology) Resident Affiliation IPGMER and SSKM Hospital Address Department of Endocrinology and Metabolism Room 9A 4th floor Ronald Ross Building IPGMER and SSKM Hospital 244 AJC Bose Road Kolkata WEST BENGAL 700020 India Phone Fax Email [email protected] Details Contact Details Contact Person (Public Query) Person (Public Query) Name Manoj Kumar Designation DM (Endocrinology) Resident Affiliation IPGMER and SSKM Hospital Address Department of Endocrinology and Metabolism Room 9A 4th floor Ronald Ross Building IPGMER & SSKM Hospital 244 AJC Bose Road Kolkata WEST BENGAL

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700020 India Phone Fax Email [email protected] Source of Monetary or Source of Monetary or Material Support Material Support > Research Society of the Study of Diabetes in India, West Bengal Chapter Primary Sponsor Primary Sponsor Details Name Research Society for Study of Diabetes in India West Bengal Chapter Address Room 6 Department of Endocrinology and Metabolism IPGMER and SSKM Hospital Calcutta Type of Sponsor Government medical college Details of Secondary Name Address Sponsor NIL NIL Countries of List of Countries Recruitment India Sites of Study Name of Principal Name of Site Site Address Phone/Fax/Email Investigator Manoj Kumar Diabetic Clinic ROOM-9, 9A, 4th floor 9330299111 Department of Ronald Ross Building Endocrinology and Department of [email protected] Metabolism IPGMER Endocrinology And and SSKM Hospital Metabolism IPGMER & Calcutta SSKM Hospital 244 AJC Bose Road Calcutta Kolkata WEST BENGAL Details of Ethics Name of Committee Approval Status Date of Approval Is Independent Ethics Committee Committee? Institutional Ethics Approved 21/03/2013 No Committee IPGMER and SSKM Hospital Regulatory Clearance Status Date Status from DCGI Not Applicable No Date Specified Health Condition / Health Type Condition Problems Studied Healthy Human Volunteers Screened by oral glucose tolerance tests for impaired fasting glucose and or impaired glucose tolerance, a condition with high risk of progression to diabetes called Prediabetes Intervention / Type Name Details Comparator Agent Comparator Agent Placebo Empty capsules of same color and appearance given twice daily Duration: 24 months Intervention Selenium capsules containing 100mcg of selenium to be given twice daily Duration: 24 months Inclusion Criteria Inclusion Criteria Age From 40.00 Year(s) Age To 80.00 Year(s)

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Gender Both Details Individuals with persistent impaired fasting glucose (IFG) (100-125mg/dl) and/or impaired glucose tolerance (IGT) (140-199mg/dl) over 2 oral glucose tolerance tests (OGTTS) done over a week using 75 gram anhydrous glucose were included Exclusion Criteria Exclusion Criteria Details Subjects with diabetes mellitus are excluded, i.e. FPG ? 126 mg/dl or 2-hour plasma glucose ? 200 mg/dl during OGTT, Hyperthyroid patients Medical conditions likely to limit life span and/or increase risk of intervention Cardiovascular disease Hospitalization for treatment of heart disease or stroke in past 6 months New York Heart Association Functional Class > 2 Renal disease (creatinine ? 1.6 mg/dl for men or ? 1.5 mg/dl for women Hepatitis, based on history and/or serum ALT greater than 2.5 times the upper limit of normal Recent or significant abdominal Pulmonary disease with dependence on oxygen or daily use of bronchodilators Chronic infection (e.g., HIV, active tuberculosis) Patients with history of selenium supplementation Pregnancy and childbearing Currently pregnant or within 3 months postpartum Currently nursing or within 6 weeks of having completed nursing Medications and medical conditions likely to confound the assessment for diabetes, including Thiazide diuretics at a dose greater than 25 mg/day Non-cardioselective beta-blockers, systemic Niacin (individuals receiving treatment with a statin or fenofibrate will not be excluded as long as the dose has been stable for 3 months prior to randomization) Glucocorticoids, systemic Prescription weight-loss or weight-gain medications Method of Generating Computer generated randomization Random Sequence Method of Case Record Numbers Concealment Blinding/Masking Participant and Investigator Blinded Primary Outcome Outcome Timepoints Progression to diabetes (fasting blood Outcomes assessed every 3 months during glucose125mg/dl or 2h post glucose blood follow up glucose199mg/dl)

Reversal to normoglycemia (fasting blood glucose100mg/dl and 2h post glucose blood glucose 140mg/dl) Secondary Outcome Outcome Timepoints NIL NIL Target Sample Size Total Sample Size=200 Sample Size from India=200 Final Enrollment numbers achieved (Total)=Applicable only for Completed/Terminated trials Final Enrollment numbers achieved (India)=Applicable only for Completed/Terminated trials Phase of Trial N/A

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Date of First 01/04/2013 Enrollment (India) Date of First No Date Specified Enrollment (Global) Estimated Duration of Years=3 Trial Months=0 Days=0 Recruitment Status of Not Applicable Trial (Global) Recruitment Status of Open to Recruitment Trial (India) Publication Details Not yet published Brief Summary PARAMETERS TO BE STUDIED:

1) Fasting blood sugar and 2 hour post 75 grams glucose (Oral Glucose tolerance test)

2) Fasting serum insulin (for calculation of HOMA-IR and QUICKIE)

3) Fasting hs-CRP, IL-6 and TNF- alpha (systemic inflammatory markers)

4) Fasting serum Selenoprotein P and Glutathione Peroxidase

5) Fasting lipid profile

6) Liver function tests (Bilirubin, albumin, globulin, AST, ALT, ALP)

7) Renal function tests (urea, creatinine)

STUDY TOOLS & STUDY TECHNIQUE:

Patients and their family members attending diabetic clinic or endocrine outpatient department (OPD) services of SSKM Hospital and IPGMER will be considered. Patients >40 years and <80 years of age will be considered. Family members of diabetic patients who give consent would be screened by 75 gm OGTT with glucose measured at fasting and 2 hours post glucose. Patients attending OPD with reports of impaired fasting glucose (IFG; 100-125mg/dl)

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and/or impaired glucose tolerance (IGT; 140-199mg/dl) would also undergo the same 75 gm OGTT and blood glucose would be measured. Patients with fasting blood glucose between 100-125 mg/dl or 2 hour post meal blood glucose between 140-199mg/dl, documented at least twice separately on different days over a week period would only be considered for the study. Treated patients of hypothyroidism who are clinically and biochemically euthyroid will be considered for the study.

The patients would be explained about the study and only those who give informed written consent would be included in the final study. Clearance from the Institutional Ethics committee will be obtained before the study initiation. The finally included patients in the study would be given an appointment to attend the OPD services after a 12 hour fast.

Height (to ±0.1 cm) will be measured in all included patients at baseline using a wall-mounted stadiometer, and body weight (to ± 100 g) will be measured using an electronic calibrated scale (BMI will be calculated as weight in kilograms divided by the square of height in meters (kg/m2). Waist circumference, hip circumference will be measured in all patients and waist-hip ratio (WHR) and waist –height ratio (WHtR) will be calculated as a measure of truncal obesity. Data on age, sex, and smoking status (never, past, or current) will be collected. Leisure, household, and occupational activity levels will be estimated at baseline. All patients would undergo detailed clinical examination.

Blood samples would then be collected. Plasma and serum collected will be stored at -80°C. Plasma glucose will be measured by an oxygen rate method. Serum insulin will be measured by radioimmunoassay commercial kit. Plasma levels of circulating inflammatory marker (hs-CRP) would be measured. Lipid profile, serum creatinine and electrolytes would be estimated in all patients. Serum Selenoprotein P and Glutathione Peroxidase levels will be measured using ELISA kit.

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All patients will undergo assessment of insulin sensitivity in the basal (non-stimulated) state by the homeostasis model assessment of insulin resistance (HOMA-IR) based on fasting glucose and insulin measurements: HOMA-IR = (glucose [mg/dl] * insulin [mU/l])/405 (21). Pancreatic ? cell function will be estimated by HOMA modeling of ? cell function: HOMA-?= 360* insulin [mU/l]/ glucose [mg/dl]-63. High HOMA-IR scores denote low insulin sensitivity (increased insulin resistance). HOMA-IR has a high correlation with measures of insulin sensitivity obtained from the euglycemic clamp procedure.

Most of the investigations will be obtained from Laboratory of IPGMER & SSKM Hospital & Laboratory of Department of Endocrinology and Metabolism, IPGMER & SSKM Hospital.

INTERVENTION:

The selected individuals will be randomized into 2 groups by a computer generated randomization table

GROUP-A: Prediabetes individuals receiving selenium supplementation (Capsule selenium 200mcg/d) daily for the duration of the study

GROUP-B: Prediabetes individuals receiving placebo (Placebo capsules of similar appearance/d) daily for the duration of the study)

The patient as well as the investigator interacting with the patient shall be blinded to the nature of the treatment given.

All patients will be followed up 3 monthly for the duration of the study in the diabetic clinic of the department. During follow up, empty bottles of the capsules administered will be collected back, compliance checked, enquired for any side effects and any complaints noted. All patients will undergo detailed clinical

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examination and blood sampling for biochemical analysis of the above mentioned parameters.

If the patient has progressed to any of the end-points (outcomes), the patient shall then be excluded from the study, groups revealed and further management shall be given accordingly. The patient shall continue to follow up in the diabetic clinic.

The individuals shall receive regular phone calls and SMS to ensure compliance and for enquiry of complications

PLANS FOR ANALYSIS OF DATA

Statistical Analysis

Student’s t test will be used for analysis of continuous variables, Fisher’s exact test for binary variables, and the ?2 test will be used for categorical variables. All results of continuous variables will be expressed as mean ± SD.

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