A non-invasive approach for risk evaluation of Type 2 Diabetes and Hypertension for patients who are at-risk

A non-invasive approach for Type 2 Diabetes and Hypertension risk evaluation in at-risk patients.

Status

Active, not recruiting

Phases

Phase 1Phase 2

Study type

Observational

Source

CTRI

Registry ID

CTRI/2020/11/028880

Enrollment

500

Registered

2020-11-04

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: E115- Type 2 diabetes mellitus with circulatory complications

Interventions

None listed

Eligibility

Inclusion criteria

Inclusion criteria: Age greater than 30 years with one or more of the following risk factors: BMI > 25 kg/mÂ² Elevated waist circumference, > 35 inches for women and > 40 inches for men Habitually physically inactive (does not exercise regularly) Has delivered a baby weighing > 4kg or diagnosed with gestational diabetes Hypertension (>=130/>= 85 mmHg) or being treated for hypertension HDL cholesterol level = 250 mg/dL or being treated for dyslipidemia with medication Has insulin resistance which can be identified using HOMMA-IR modelling Has been previously diagnosed with Polycystic Ovary Syndrome (PCOS) Had impaired glucose tolerance or impaired fasting glucose on previous testing within the last three years

Exclusion criteria

Exclusion criteria: Under 25 years of age Receiving investigational treatments in the past 14 days Psychosocial issues that interfere with an ability to follow study procedures Current chemotherapy, or chemotherapy within the past 12 months Receiving medications that fluoresce Known to have, or at risk for, photosensitivity reactions ( e.g., sensitive to ultraviolet light, or taking medication known to cause photosensitivity)

Design outcomes

Primary

Measure	Time frame
The primary outcome of the trial will be a model based evaluation system to identify at risk type 2 diabetes patientsTimepoint: 8 weeks	—

Secondary

Measure	Time frame
The secondary outcome will be identifying patients who are at risk for vascular complications like hypertensionTimepoint: 8 weeks	—

Countries

India

Contacts

Public ContactGayathri Choda

SRM Institute of Science and Technology

jayantht@srmist.edu.in9840490315

Outcome results