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

Phase 1
Conditions
Health Condition 1: E115- Type 2 diabetes mellitus with circulatory complications
Registration Number
CTRI/2020/11/028880
Lead Sponsor
Aarca Research India Pvt Ltd
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
ot Yet Recruiting
Sex
Not specified
Target Recruitment
0
Inclusion Criteria

Age greater than 30 years with one or more of the following risk factors:

BMI > 25 kg/m²

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 < 35 mg/dL and/or a fasting triglyceride 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

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)

Study & Design

Study Type
Observational
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
The primary outcome of the trial will be a model based evaluation system to identify at risk type 2 diabetes patientsTimepoint: 8 weeks
Secondary Outcome Measures
NameTimeMethod
The secondary outcome will be identifying patients who are at risk for vascular complications like hypertensionTimepoint: 8 weeks
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