Blood levels of antitubercular drugs in TB patients associated with diabetes mellitus

Not Applicable

Conditions: Health Condition 1: J00-J99- Diseases of the respiratory systemHealth Condition 2: E00-E89- Endocrine, nutritional and metabolic diseases

Registration Number: CTRI/2021/08/035578

Lead Sponsor: Maulana Azad Medical College

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Yet Recruiting

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

1)Newly diagnosed pulmonary tuberculosis patients taking daily antitubercular drugs according to NTEP guidelines(2019)

2)Patiients diagnosed with type 2 diabetes mellitus( on diet control or oral antidiabetic drugs or fasting BG >126mg/dl or postprandial BG >200 mg/dl or random BG >200mg/dl or HbA1c >6.5%

3) Sensitive to rifampicin detectced by cartridge based nucleic acid amplification test(CBNAAT)

Exclusion Criteria

Patients with

1)Abnormal liver function tests(AST or ALT or both >50 IU)

2) Abnormal renal function tests( Creatinine >1.5mg/dl and urea >40 mg/dl)

3) Pregnant and nursing mothers

4) On concomitant Anti retroviral treatment

5) On immunosuppressive medication

6) On corticosteroid therapy

7) Body weight less than 30kg

8)sick or moribund patients

9)Patients developing severe adverse drug reactions during treatment

Study & Design

Study Type: Observational

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1) Drug levels of isoniazid, rifampin, pyrazinamide and ethambutol over 12 hours after drug administration <br/ ><br>2) Pharmacokinetics parameters-peak serum concentration(Cmax), Time to reach peak serum plasma concentration( Tmax), Absorption rate constant(kab), volume of distribution(vd), area under <br/ ><br> plasma concentration time curve(AUC 0-24), area under plasma concentration time curve infinity, elimination half life, elimination rate Constant, Clearance <br/ ><br> <br/ ><br>Timepoint: 0,1,2,3,4,8,12 hours after drug administration

Secondary Outcome Measures

Name	Time	Method
Association and resolution of clinical symptoms(fever, increase appetite, weight gain) with coexisting diabetes mellitus, antitubercular drug levelsTimepoint: after 2months and 6months of antitubercular therapy initiated;Association between sputum conversion and status of diabetes mellitusTimepoint: At the end of 2months and 6months of antitubercular therapy;Correlation between peak drug concentration of antitubercular drugs and sputum conversionTimepoint: at the end of 2 months and 6months of antitubercular therapy started;Sputum conversion(ZN stain and MGIT culture)Timepoint: at the end of 2months and 6months of antitubercular therapy