An intervention examining the effect of an intensive lifestyle intervention consisting of a low energy diet and physical activity on weight loss in subjects with early type 2 diabetes.

Plain English Summary

Background and study aims
Diabetes is a condition where a person has too high or uncontrollable blood sugar levels. Diabetes is one of the greatest challenges faced by healthcare services worldwide. It is associated with serious complications such as heart attacks, stroke, and peripheral artery disease as well as kidney disease, eye disease, and nerve dysfunction. Data from weight loss with bariatric surgery suggest that with the appropriate intervention, it should be possible to reverse diabetes and that the earlier the intervention occurs, the greater the chances of placing diabetes into remission. There is now a need to translate this knowledge into the medical care of younger patients with early diabetes who are overweight/obese. The aim of this study is to see if younger adult patients with overweight/obesity and type 2 diabetes who are participants in a programme incorporating a low energy diet and physical activity (lifestyle) will lower their weight, cardiovascular risk and improve their glycaemic control as compared to the usual care.

Who can participate?
Adults aged 18 to 50 years who have type 2 diabetes.

What does the study involve?
Participants are randomly allocated to one of two groups. Those in the first group consume low energy meal replacements followed by gradual food reintroduction and increase in physical activity levels for 12 months. Those in the second group receive the standard medical care which includes routine advice about diet and physical activity for 12 months. Participants are followed up to measure their body weight and symptoms prior to the study and at three, six, nine and 12 months.

What are the possible benefits and risks of participating?
Participants may benefit from controlling their blood sugar levels and from losing weight. Notable risks to participants include low blood sugar and feeling discomfort when providing blood samples. Participants may also feel burdened by the time commitment.

Where is the study run from?
The study is being run by Weill Cornell Medicine (Qatar) and takes place in the Hamad Medical Corporation hospitals in Doha (Qatar), Primary Health Care Corporation health centres in Doha (Qatar) and at the Qatar Diabetes Association(Qatar).

When is the study starting and how long is it expected to run for?
May 2015 to December 2020

Who is funding the study?
Qatar National Research Fund (Qatar)

Who is the main contact?
Prof. Shahrad Taheri
szt2004@qatar-med.cornell.edu

Study website

Type

Public

Contact name

Prof Shahrad Taheri

ORCID ID

http://orcid.org/0000-0001-8314-1500

Contact details

Department of Medicine
Weill Cornell Medicine
PO box 24144
Doha
PO24144
Qatar
+974 4492 8470
szt2004@qatar-med.cornell.edu

EudraCT/CTIS number

IRAS number

ClinicalTrials.gov number

NCT03225339

Secondary identifying numbers

NPRP 8-912-3-192

Scientific title

Diabetes Intervention Accentuating Diet and Enhancing Metabolism (DIADEM-I): a randomised controlled trial assessing the impact of low energy diet and activity on body weight and glycaemia in diabetes

Acronym

DIADEM-I

Study hypothesis

Patients in the low energy and physical activity (lifestyle) intervention arm will have greater weight reduction leading to significant improvements in glycaemic control and cardiovascular risk compared to the usual clinical care arm.

Ethics approval(s)

1. Weill Cornell Medicine, Qatar IRB, 29/10/2015, ref: 15-00071
2. Hamad Medical Corporation, Qatar IRB, 04/11/2015, ref: 15395/15
3. Primary Healthcare Corporation, Qatar IRB, 14/03/2017, ref: PHCC/IEC/17/02/002

Study design

Prospective parallel group randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Study setting(s)

GP practice

Study type

Treatment

Patient information sheet

Not available in web format, please use the contact details to request a patient information sheet

Condition

Type 2 Diabetes Mellitus

Intervention

Participants are randomly allocated to one of two groups.

Group 1 Lifestyle Intervention [low energy diet and physical activity]: Participants in this group use low energy meal replacement products in combination with physical activity, followed by gradual introduction of food, and increasing physical activity. Behavioural support for the lifestyle intervention is also provided.

Group 2 Usual Medical Care: Participants in this group receive the standard treatment based on current clinical practice aiming to reduce diabetes symptoms and complications, and general recommendations on diet and physical activity.

Participants are enrolled in the treatment for 12 months. Participants are followed up at baseline, three, six, nine, and 12 months.

Intervention type

Mixed

Primary outcome measure

Body weight is measured using Tanita scales at baseline, 3 months, 6 months, 9 months, and 12 months.

Secondary outcome measures

1. Diabetes control is measured biochemically using HbA1c and fasting glucose at baseline, 3 months, 6 months, 9 months, and 12 months
2. Medication use is recorded using patient medical records at baseline, 3 months, 6 months, 9 months, and 12 months
3. Body composition is measured using bioimpedance (Tanita) at baseline, 3 months, 6 months, 9 months, and 12 months
4. Physical activity levels are measured using International Physical Activity Questionnaire (IPAQ), GT3X+ accelerometers, and SIT-Q-7d questionnaire for sedentariness at baseline, 3 months, 6 months, 9 months, and 12 months
5. Cardiovascular health and markers are measured blood pressure, heart rate, ankle-brachial pressure index, Vicorder and dynamic visual analyser testing, dyslipidaemia (triglycerides, total cholesterol, LDL-cholesterol, HDL-cholesterol), hsCRP (high sensitivity C-reactive protein) at baseline, 3 months, 6 months, 9 months, and 12 months
6. Quality of life is measured using Euro-QoL-5D and a weight-specific quality of life questionnaire (IWQOL-LITE) at baseline, 3 months, 6 months, 9 months, and 12 months

Overall study start date

12/05/2015

Overall study end date

31/12/2020

Reason abandoned (if study stopped)

Participant inclusion criteria

1. Type 2 diabetes mellitus
2. Diabetes of ≤ 3-year duration
3. BMI ≥27.0 kg/m²
4. Men and women
5. Age 18-50 years
6. Originating from the Middle East and North Africa region and resident in Qatar
7. Able to commit to the study duration
8. Able to give informed consent and willing to participate in the study

Participant type(s)

Patient

Age group

Adult

Lower age limit

18 Years

Upper age limit

50 Years

Sex

Both

Target number of participants

138

Total final enrolment

158

Participant exclusion criteria

1. Type 1 diabetes mellitus based on clinical history
2. Cardiovascular event in the previous 6 months
3. Chronic kidney disease stage 3b or greater (eGFR <30 mL/min/1.73 m²)
4. Currently pregnant, lactating, or planning pregnancy within the study period
5. Any condition precipitating fluid overload such as heart failure (NYHA class > I) and liver cirrhosis
6. Significant previously diagnosed psychiatric disorder (e.g. schizophrenia, post-traumatic stress disorder, obsessive-compulsive disorder)
7. Uncontrolled depression
8. Uncontrolled epilepsy
9. Known lactose intolerance
10. Severe arthritis preventing walking
11. Active gout
12. Active gallstone disease or known asymptomatic gallstones

Recruitment start date

01/03/2017

Recruitment end date

28/02/2018

Countries of recruitment

Qatar

Study participating centre

Hamad Medical Corporation (HMC)
Al Rayyan Road
PO 3050
Doha
PO3050
Qatar

Study participating centre

Qatar Diabetes Association (QDA)
Rawdat Al Khail
Al Muntaza
PO 752
Doha
PO752
Qatar

Study participating centre

Primary Health Care Corporation
Rawdat Al-Khail Street B Ring Road
Doha
PO 26555
Qatar

Organisation

Weill Cornell Medicine in Qatar

Sponsor details

Qatar Foundation
Education City
Doha
PO 24144
Qatar

Sponsor type

University/education

Website

https://qatar-weill.cornell.edu/

ROR

https://ror.org/05v5hg569

Funder type

Research organisation

Funder name

Qatar National Research Fund

Alternative name(s)

صندوق قطر الوطني للبحوث, QNRF

Funding Body Type

private sector organisation

Funding Body Subtype

Trusts, charities, foundations (both public and private)

Location

Qatar

Publication and dissemination plan

Publication is planned in high-impact peer reviewed journals and through an effective dissemination plan, the study will aim to inform current diabetes care provision in Qatar and other countries.

Intention to publish date

31/12/2020

Individual participant data (IPD) Intention to share

No

IPD sharing plan

The current data sharing plans for the current study are unknown and will be made available at a later date.

IPD sharing plan summary

Data sharing statement to be made available at a later date

Study outputs