Participant section

Participant section

[intense_tabs animation=”cycle-up” tab_1261612438=”” tab_1817541942=””][intense_tab title=”What is diabetes?” border=”0px solid #e8e8e8″ icon_size=”1″ tab_1680897507=”” tab_1807433145=”” tab_1342351646=”” tab_1150565022=””]

What is Diabetes?

Diabetes is a chronic disease that affects the body’s ability to convert sugar into energy. This occurs when the pancreas is no longer able to produce insulin, or when the body cannot make proper use of the insulin produced.

Sugar (glucose) levels build up in the blood when pancreas is not able to produce insulin or to use it effectively.

There are different types of diabetes but the three main types are:

  • Type 1 Diabetes
  • Type 2 Diabetes
  • Gestational Diabetes

Type-2 Diabetes is the fifth leading cause of death worldwide, and a major contributor to development of coronary heart disease, stroke, peripheral vascular disease and end-stage renal failure. The International Diabetes Federation reports that the number of people with T2D will rise from 382 million to 592 million between 2013 and 2035.

This project studies T2D in South Asian population, who represent one-quarter of the world’s population with Type 2 Diabetes.

India alone has ~56 million people with T2D, the second highest number in the world.

Estimates show that T2D cases in India will increase to ~100 million by 2030. T2D prevalence is currently ~9% in rural India, ~18% in urban India, and ~22% amongst Indians living in Europe (compared to ~6% among Europeans). Similar patterns are observed among South Asians in Pakistan, Bangladesh, and Sri Lanka.[/intense_tab][intense_tab title=”Eligibility Criteria” border=”0px solid #e8e8e8″ icon_size=”1″ tab_1680897507=”” tab_1807433145=”” tab_1342351646=”” tab_1150565022=””]Status: Ethics approval pending

Eligibility criteria

Inclusion criteria: South Asian, Waist circumference≥100cm OR HbA1c≥6.0%, 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.

A family-based approach

Previous studies in European populations show that intensive lifestyle modifications is associated with reduction in the incidence of T2D in people at risk of developing diabetes. We are now applying this method to the Asian population.

The iHealth-T2D study aims to recruit 3,600 South Asian men and women aged 40-70 years with central obesity or prediabetes to take part of the study. The patient recruitment will take place in United Kingdom, India, Pakistan and Sri Lanka. If you choose to join this study, you will take part for a period of 4 years. During this period you will either be part of the intervention group or control group. The group you are allocated to will be decided by a process called randomisation. This means that you will be randomly assigned to a group, have an equal chance of being allocated to any of the two groups and you will not be able to choose the group you are in.[/intense_tab][intense_tab title=”Control Group” border=”0px solid #e8e8e8″ icon_size=”1″]

Randomisation for Intervention  or Control Group

[intense_table columns=”Intervention Group,Control Group” data=”1 initial session with our Community Health Worker follow by 21 contact sessions over 12 months,1 single session with our Community Health Worker over 12 months,3 follow-up sessions, 1 time a year,3 follow-up sessions, 1 time a year” heading_background_color=”#163f71″ heading_font_color=”#ffffff” bordered=”1″]

The control group is expected to attend one single session with a Health Community Worker, during the first year and then to attend the follow-up appointments 1 time a year, for 3 years

On the other hand, the intervention group involves 22 sessions about lifestyle modifications. The sessions are delivered over 12 months by a Community Health Worker. The participants are strongly encouraged to involve all family members, particularly if they are overweight or the main cook(s) of the family.

After the intervention phase, the participant enters a more independent phase, the follow-up, in which he/she is asked to continue applying  all the lessons learned in the past year. The Participant is constantly encouraged to keep the other family members involved.

During the follow-up phase the participant will book an appointment with one of our Research Nurses, once a year, for 3 years. During the appointment the Research Nurse will ask the participant for three things:

  • To complete questionnaires about his/her health, background and lifestyle
  • Have some simple physical measurement (e.g. height, weight, blood pressure)
  • Give a small blood sample (1 spoon) for testing sugar and metabolism.

[/intense_tab][intense_tab title=”Ethics and Regulatory Approvals” border=”0px solid #e8e8e8″ icon_size=”1″ tab_1680897507=”” tab_1807433145=”” tab_1342351646=”” tab_1150565022=””]

Ethics and regulatory approvals

iHealth-T2D is a project funded by European Commission’s Research and Innovation Programme, Horizon 2020, and sponsored by Imperial College London.

This study will not open to recruitment until appropriate approvals and authorisations have been obtained from an independent ethical committee. In the same way, recruitment will not commence at an individual participating site until local NHS Management approval has been obtained and all local documentation is in place and all requirements have been fulfilled according to this project’s Standard Operating Procedures (SOPs).[/intense_tab][/intense_tabs]


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