Diabetes Mellitus, Type 2 Clinical Trial
Official title:
Evaluation of an Integral Strategy for Joint Management of DM2 and Pulmonary TB in Orizaba, Veracruz.
The objective of this study is to evaluate an integral strategy in which diabetes mellitus 2 (DM2) and pulmonary tuberculosis (TB) are managed together. The researchers propose a community intervention with two arms in 4 health centers in Orizaba, Veracruz. Patients will be assigned to either arm by convenience. One arm will receive the joint treatment strategy and another the routine treatment used in health services.
In Mexico DM2 is the main complication of patients with TB (22.2%), more so than HIV,
malnutrition and chronic pulmonary obstructive disease (COPD).
The World Health Organization (WHO) has proposed a framework for the joint management of TB
and DM2 and one of the key points is the need for studies that evaluate the viability and
efficacy of programs that manage both diseases jointly. There are social and clinical
determinants that are associated to a higher mortality in patients with DM2 and TB such as
poor glucose level control (glycosylated hemoglobin >7mg/dl) and immunosuppression which in
turn increases the risk of developing a recurrent episode of TB, being multi drug resistant
(MDR) and/or failing TB treatment. The determinants associated to TB are the lack of
awareness of the disease, drug toxicity and interaction with DM2 medication and treatment
default. Social determinants are low income level, living in a crowded household, living in
rural areas, not having access to health care, having been in prison and living with people
with TB.
The strategy consists of interventions on patients, health personnel, community health
workers and directors of health services. Researchers will train patients in the use of
glucometers, health personnel in management of comorbidities of DM2 and TB, health workers in
how to support patients and increase treatment adherence. Bidirectional screening in patients
with TB or DM2 using bacilloscopies and glycosylated hemoglobin (HbA1c). During the 6 months
of directly observed treatment (DOTS) study nurses will monitor levels of glucose weekly with
capillary glucose, monthly with fasting glucose, in months 1, 3 and 6 with HbA1c. Patients
with high glucose levels will be referred to metabolic control which will be assessed by
experts. Regarding DOTs, first line TB drugs will be available and study nurses will
supervise that they are taken correctly. A nutritionist will carry out home visits to guide
dietary intake.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Active, not recruiting |
NCT05666479 -
CGM Monitoring in T2DM Patients Undergoing Orthopaedic Replacement Surgery
|
||
| Completed |
NCT05647083 -
The Effect of Massage on Diabetic Parameters
|
N/A | |
| Active, not recruiting |
NCT05661799 -
Persistence of Physical Activity in People With Type 2 Diabetes Over Time.
|
N/A | |
| Completed |
NCT03686722 -
Effect of Co-administration of Metformin and Daclatasvir on the Pharmacokinetis and Pharmacodynamics of Metformin
|
Phase 1 | |
| Completed |
NCT02836704 -
Comparison of Standard vs Higher Starting Dose of Insulin Glargine in Chinese Patients With Type 2 Diabetes (Glargine Starting Dose)
|
Phase 4 | |
| Completed |
NCT01819129 -
Efficacy and Safety of FIAsp Compared to Insulin Aspart in Combination With Insulin Glargine and Metformin in Adults With Type 2 Diabetes
|
Phase 3 | |
| Completed |
NCT04562714 -
Impact of Flash Glucose Monitoring in People With Type 2 Diabetes Using Non-Insulin Antihyperglycemic Therapy
|
N/A | |
| Completed |
NCT02009488 -
Treatment Differences Between Canagliflozin and Placebo in Insulin Secretion in Subjects With Type 2 Diabetes Mellitus (T2DM)
|
Phase 1 | |
| Completed |
NCT05896319 -
Hyaluronic Acid Treatment of the Post-extraction Tooth Socket Healing in Subjects With Diabetes Mellitus Type 2
|
N/A | |
| Recruiting |
NCT05598203 -
Effect of Nutrition Education Groups in the Treatment of Patients With Type 2 Diabetes
|
N/A | |
| Completed |
NCT05046873 -
A Research Study Looking Into Blood Levels of Semaglutide and NNC0480-0389 When Given in the Same Injection or in Two Separate Injections in Healthy People
|
Phase 1 | |
| Completed |
NCT04030091 -
Pulsatile Insulin Infusion Therapy in Patients With Type 1 and Type 2 Diabetes Mellitus
|
Phase 4 | |
| Terminated |
NCT04090242 -
Impact of App Based Diabetes Training Program in Conjunction With the BD Nano Pen Needle in People With T2 Diabetes
|
N/A | |
| Completed |
NCT03620357 -
Continuous Glucose Monitoring & Management In Type 2 Diabetes (T2D)
|
N/A | |
| Completed |
NCT03604224 -
A Study to Observe Clinical Effectiveness of Canagliflozin 300 mg Containing Treatment Regimens in Indian Type 2 Diabetes Participants With BMI>25 kg/m^2, in Real World Clinical Setting
|
||
| Completed |
NCT01696266 -
An International Survey on Hypoglycaemia Among Insulin-treated Patients With Diabetes
|
||
| Completed |
NCT03620890 -
Detemir Versus NPH for Type 2 Diabetes Mellitus in Pregnancy
|
Phase 4 | |
| Withdrawn |
NCT05473286 -
A Research Study Looking at How Oral Semaglutide Works in People With Type 2 Diabetes in Germany, as Part of Local Clinical Practice
|
||
| Not yet recruiting |
NCT05029804 -
Effect of Walking Exercise Training on Adherence to Disease Management and Metabolic Control in Diabetes
|
N/A | |
| Completed |
NCT04531631 -
Effects of Dorzagliatin on 1st Phase Insulin and Beta-cell Glucose Sensitivity in T2D and Monogenic Diabetes
|
Phase 2 |