Tuberculosis, malnutrition, diabetes Infections and Infestations Tuberculosis, malnutrition, diabetes
Conditions
Interventions
Participants initiating a new TB treatment regimen are invited to join the study, and are followed up every month until treatment completion. At the time of enrolment, participants are asked if they w
Sponsors
Nagasaki University
Eligibility
Sex/Gender
All
Age
18 Years to 110 Years
Inclusion criteria
Inclusion criteria: Aged 18 or more (adults) who are initiating a new TB treatment regimen
Exclusion criteria
Exclusion criteria: 1. Pregnant woman 2. Plan to move away from the study site or do not give consent to participate 3. Started the current ATT regimen more than 5 days before enrolment 4. Currently imprisoned 5. Severe medical or psychiatric disorder which in the opinion of the local investigators might interfere with the ability to give true informed consent or to adhere to the study requirements 6. Taking part in any investigational product trials related to TB and/or lung disease or diabetes.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse TB treatment outcome at end of study defined as death, loss to follow-up, default (two or more consecutive months of interrupted treatment) or treatment failure. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Adverse treatment outcome in the secondary outcome also includes relapse/ recurrent active TB diagnosed clinically or bacteriologically confirmed within 2 years of completing treatment. 2. Catastrophic household expenditure assessed by measuring total patient costs (direct medical costs, direct on-medical costs, indirect costs and coping strategies) using an adapted version of the WHO costing tool, with data collected at the start of treatment, end of intensive treatment phase, mid continuation phase and end of treatment 3. Reduced lung function assessed using the St Georges Respiratory Questionnaire and FEV1 measured by spirometry at the start of treatment, end of intensive treatment phase, mid continuation phase and end of treatment 4. Development/evolution of hyperglycaemia and diabetes. For participants with newly diagnosed diabetes during TB treatment, we will assess the proportion who remain diabetic during post-treatment follow-up. Conversely, we will assess the proportion who were non-diabetic during TB treatment who become diabetic during post-treatment follow-up (HbA1c >=6.5% or diagnosed externally and placed on treatment) Exposures outcomes: 1. Diabetes – primary exposure will be diabetes present at any one time point during treatment (HbA1c >= 6.5% or on recognized drug treatment for diabetes), secondary will be HbA1C >= 7% at 2 or more time points or on recognized drug treatment for diabetes. Exploratory analysis will assess the effect of degree of hyperglycaemia during treatment on TB treatment outcomes 2. Malnutrition - primary exposure will be moderate/severe malnutrition at the start of treatment defined as BMI< 17kg/m². Secondary analyses will explore the effect of changes in nutritional status during treatment using repeated measures analysis. Risk of recurrent TB will be explored by BMI status (moderate/severe malnutrition) at the end of TB treatment as the primary analysis Co-factors outcomes: Measured during treatment: 1. Demographic fac | — |
Countries
Philippines
Contacts
Public ContactShuichi Suzuki
Outcome results
None listed