Prevention of Type 2 Diabetes Amongst South Asians With Central Obesity and Prediabetes

Type 2 Diabetes Clinical Trial

— iHealth-T2D  

Official title:

Lifestyle Intervention to Prevent Type 2 Diabetes Amongst South Asians With Central Obesity and Prediabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02949739
• Other study ID #: 16SM3246
• Status: Completed
• Phase: N/A
• Start date: January 2015
• Est. completion date: December 31, 2022

Study information

• Verified date: March 2024
• Source: Imperial College London
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The investigators' general goal is to identify approaches to risk stratification and health promotion through lifestyle modification that are acceptable, effective and efficient for prevention of T2D in South Asian communities from diverse settings.

Description:

The specific aims of the proposed iHealth-T2D study are:

1. Determine whether intensive lifestyle modification vs usual care reduces risk of T2D (primary endpoint) amongst South Asians with i. central obesity; ii. prediabetes and iii. overall (with central obesity and / or obesity).

2. Investigate secondary endpoints, including health gains in family members. Identify social, demographic and environmental factors influencing primary and secondary endpoints.

3. Carry out a health economic analysis of lifestyle modifications vs usual care for prevention of T2D on the Indian subcontinent and Europe. Quantify the cost-effectiveness of screening by waist circumference vs HbA1c.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5244
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 70 Years

Eligibility

Inclusion Criteria:

• Waist circumference=100cm OR HbA1c=6.0%

• South Asian, Male or Female, and age 40-70 years

Exclusion Criteria:

• Known type 1 or 2 diabetes

• Fasting glucose=7.0 mmol/L or HbA1c =6.5%

• Normal or underweight (body mass index<22kg/m2)

• Pregnant or planning pregnancy

• Unstable residence or planning to leave the area

• Serious illness

• Lack of capacity to consent

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Obesity, Abdominal
• Prediabetic State
• Type 2 Diabetes

Intervention

Behavioral:
• Intensive lifestyle modification
The intervention is delivered as 9 face-face and 13 telephone contact sessions over 12 months. Index cases are the focus for the intervention, but lifestyle modification encourages the whole family to adopt healthy living.

Locations

Country	Name	City	State
United Kingdom	Imperial College London	London

Sponsors (2)

Lead Sponsor	Collaborator
Imperial College London	London North West Healthcare NHS Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	>7% reduction in weight	The investigators aim to achieve this outcome by motivating study participants to improve diet habits and increase physical activity	4 year
Secondary	Reduction of =5 cm waist circumference	The investigators aim to motivate the participants to adopt a healthier lifestyle in order to achieve at least 5cm waist circumference reduction	4 year