Health Condition 1: E119- Type 2 diabetes mellitus without complications
Conditions
Interventions
Intervention1: sulfonylurea or DPP-4 inhibitor: Add-on sulfonylurea or DPP-4 inhibitor as per the treating physicians decision
Control Intervention1: DPP-4 inhibitor: Given as per the decision of trea
Sponsors
Dr Vangaveti Sneha
Eligibility
Inclusion criteria
Inclusion criteria: 1. Participants clinically diagnosed as type 2 diabetes mellitus whose blood glucose levels are not adequately controlled with their current treatment plan and need to be started on add- on therapy (DPP-4 inhibitors/ sulfonylureas) 2. Participants with a minimum education up to higher secondary for better understanding of study procedures 3. Participants who can read and understand Hindi or English 4. Participants willing to participate and give informed consent
Exclusion criteria
Exclusion criteria: 1. Participant with HbA1c > 10% 2. Participants clinically diagnosed with any neurodegenerative disorder or psychiatric illness at the time of enrolment 3. Participants on any drug or with history of any substance abuse which are known to affect memory and cognition 4. Participants suffering from any chronic disease (like cardiac disease, peptic ulcer, respiratory disease, liver disease, kidney disease, any malignancy) 5. Pregnant and lactating women
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate and compare the effect of add-on treatment with DPP-4 inhibitors or sulfonylureas upon serum levels of biomarkers for cognitive impairment (BDNF and tau protein)after minimum 6 months of treatment in young and middle-aged adults with type 2 diabetes mellitusTimepoint: At enrolment and after 6 months of treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| To compare the serum biomarker levels and clinical assessment scores between young and middle-aged adults of type 2 diabetes mellitus and age matched controls at the time of enrolmentTimepoint: At enrolment;To evaluate and compare the effect of antidiabetic medication on clinical assessment scoresTimepoint: At enrolment and after 6 months of treatment;To evaluate and compare the effect of antidiabetic medication on clinical assessment scores for depressionTimepoint: At enrolment and after 6 months of treatment;To evaluate the relationship between the glycaemic status, extent of cognitive impairment and depression with serum biomarker levelsTimepoint: At enrolment and after 6 months of treatment | — |
Countries
India
Contacts
Public ContactVangaveti Sneha
AIIMS, New Delhi
Outcome results
None listed