Diabetes Intervention Accentuating Diet and Enhancing Metabolism (DIADEM-I): a randomised controlled trial to examine the impact of an intensive lifestyle intervention consisting of a low-energy diet and physical activity on body weight and metabolism in early type 2 diabetes mellitus: study protocol for a randomized controlled trial

Shahrad Taheri; Odette Chagoury; Hadeel Zaghloul; Sara Elhadad; Salma Hayder Ahmed; Omar Omar; Sherryl Payra; Salma Ahmed; Neda El Khatib; Rasha Abou Amona; Katie El Nahas; Matthew Bolton; Henem Chaar; Noor Suleiman; Amin Jayyousi; Mahmoud Zirie; Ibrahim Janahi; Wahiba Elhag; Abdulla Alnaama; Abduljaleel Zainel; Dahlia Hassan; Tim Cable; Mary Charlson; Martin Wells; Abdulla Al-Hamaq; Samya Al-Abdulla; Abdul Badi Abou-Samra

doi:10.1186/s13063-018-2660-1

Diabetes Intervention Accentuating Diet and Enhancing Metabolism (DIADEM-I): a randomised controlled trial to examine the impact of an intensive lifestyle intervention consisting of a low-energy diet and physical activity on body weight and metabolism in early type 2 diabetes mellitus: study protocol for a randomized controlled trial

Shahrad Taheri^*
, Odette Chagoury
, Hadeel Zaghloul
, Sara Elhadad
, Salma Hayder Ahmed
, Omar Omar
, Sherryl Payra
, Salma Ahmed
, Neda El Khatib
, Rasha Abou Amona
, Katie El Nahas
, Matthew Bolton
, Henem Chaar
, Noor Suleiman
, Amin Jayyousi
, Mahmoud Zirie
, Ibrahim Janahi
, Wahiba Elhag
, Abdulla Alnaama
, Abduljaleel Zainel

Dahlia Hassan, Tim Cable, Mary Charlson, Martin Wells, Abdulla Al-Hamaq, Samya Al-Abdulla, Abdul Badi Abou-Samra

^*Corresponding author for this work

Birmingham Clinical Trials Unit

Research output: Contribution to journal › Article › peer-review

4 Citations (Scopus)

Abstract

BACKGROUND: Type 2 diabetes mellitus (T2DM) and obesity are syndemic and will have a significant impact on affected individuals and healthcare services worldwide. Evidence shows that T2DM remission can be achieved with significant weight loss in those who are younger with early diabetes and requiring fewer medications for glycaemic control. DIADEM-I aims to examine the impact of an intensive lifestyle intervention (ILI) using a low-energy diet (LED) meal replacement approach combined with physical activity in younger individuals with early T2DM.

METHODS: The planned study is an ongoing, non-blinded, pragmatic, randomised controlled, parallel-group trial examining the impact of an LED-based ILI on body weight and diabetes remission in younger (18-50 years) T2DM individuals with early diabetes (≤ 3-year duration). The ILI will be compared to usual medical care (UMC). The primary outcome will be weight loss at 12 months. Other key outcomes of interest include diabetes remission, glycaemic control, diabetes complications, cardiovascular health, physical activity, mental health, and quality of life. It is planned for the study to include 138 subjects for assessment of the primary outcome. Safety will be assessed throughout.

DISCUSSION: If DIADEM-I demonstrates a clinically significant effect for younger individuals with early T2DM, it will inform clinical guidelines and services of the future for management of T2DM.

TRIAL REGISTRATION: ISRCTN: ISRCTN20754766 (date assigned: 7 June 2017); ClinicalTrials.gov, ID: NCT03225339 Registered on 26 June 2017.

Original language	English
Article number	284
Number of pages	14
Journal	Trials
Volume	19
Issue number	1
DOIs	https://doi.org/10.1186/s13063-018-2660-1
Publication status	Published - 21 May 2018

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

SDG 3 Good Health and Well-being

Keywords

Type 2 diabetes mellitus
Obesity
Lifestyle
Diet
Physical activity

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Taheri, S., Chagoury, O., Zaghloul, H., Elhadad, S., Ahmed, S. H., Omar, O., Payra, S., Ahmed, S., El Khatib, N., Amona, R. A., El Nahas, K., Bolton, M., Chaar, H., Suleiman, N., Jayyousi, A., Zirie, M., Janahi, I., Elhag, W., Alnaama, A., ... Abou-Samra, A. B. (2018). Diabetes Intervention Accentuating Diet and Enhancing Metabolism (DIADEM-I): a randomised controlled trial to examine the impact of an intensive lifestyle intervention consisting of a low-energy diet and physical activity on body weight and metabolism in early type 2 diabetes mellitus: study protocol for a randomized controlled trial. Trials, 19(1), Article 284. https://doi.org/10.1186/s13063-018-2660-1

Taheri, Shahrad ; Chagoury, Odette ; Zaghloul, Hadeel et al. / Diabetes Intervention Accentuating Diet and Enhancing Metabolism (DIADEM-I) : a randomised controlled trial to examine the impact of an intensive lifestyle intervention consisting of a low-energy diet and physical activity on body weight and metabolism in early type 2 diabetes mellitus: study protocol for a randomized controlled trial. In: Trials. 2018 ; Vol. 19, No. 1.

@article{4446322244494b78ab4045e350d7a541,

title = "Diabetes Intervention Accentuating Diet and Enhancing Metabolism (DIADEM-I): a randomised controlled trial to examine the impact of an intensive lifestyle intervention consisting of a low-energy diet and physical activity on body weight and metabolism in early type 2 diabetes mellitus: study protocol for a randomized controlled trial",

abstract = "BACKGROUND: Type 2 diabetes mellitus (T2DM) and obesity are syndemic and will have a significant impact on affected individuals and healthcare services worldwide. Evidence shows that T2DM remission can be achieved with significant weight loss in those who are younger with early diabetes and requiring fewer medications for glycaemic control. DIADEM-I aims to examine the impact of an intensive lifestyle intervention (ILI) using a low-energy diet (LED) meal replacement approach combined with physical activity in younger individuals with early T2DM.METHODS: The planned study is an ongoing, non-blinded, pragmatic, randomised controlled, parallel-group trial examining the impact of an LED-based ILI on body weight and diabetes remission in younger (18-50 years) T2DM individuals with early diabetes (≤ 3-year duration). The ILI will be compared to usual medical care (UMC). The primary outcome will be weight loss at 12 months. Other key outcomes of interest include diabetes remission, glycaemic control, diabetes complications, cardiovascular health, physical activity, mental health, and quality of life. It is planned for the study to include 138 subjects for assessment of the primary outcome. Safety will be assessed throughout.DISCUSSION: If DIADEM-I demonstrates a clinically significant effect for younger individuals with early T2DM, it will inform clinical guidelines and services of the future for management of T2DM.TRIAL REGISTRATION: ISRCTN: ISRCTN20754766 (date assigned: 7 June 2017); ClinicalTrials.gov, ID: NCT03225339 Registered on 26 June 2017.",

keywords = "Type 2 diabetes mellitus, Obesity, Lifestyle, Diet, Physical activity",

author = "Shahrad Taheri and Odette Chagoury and Hadeel Zaghloul and Sara Elhadad and Ahmed, \{Salma Hayder\} and Omar Omar and Sherryl Payra and Salma Ahmed and \{El Khatib\}, Neda and Amona, \{Rasha Abou\} and \{El Nahas\}, Katie and Matthew Bolton and Henem Chaar and Noor Suleiman and Amin Jayyousi and Mahmoud Zirie and Ibrahim Janahi and Wahiba Elhag and Abdulla Alnaama and Abduljaleel Zainel and Dahlia Hassan and Tim Cable and Mary Charlson and Martin Wells and Abdulla Al-Hamaq and Samya Al-Abdulla and Abou-Samra, \{Abdul Badi\}",

year = "2018",

month = may,

day = "21",

doi = "10.1186/s13063-018-2660-1",

language = "English",

volume = "19",

journal = "Trials",

issn = "1745-6215",

publisher = "Springer",

number = "1",

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Taheri, S, Chagoury, O, Zaghloul, H, Elhadad, S, Ahmed, SH, Omar, O, Payra, S, Ahmed, S, El Khatib, N, Amona, RA, El Nahas, K, Bolton, M, Chaar, H, Suleiman, N, Jayyousi, A, Zirie, M, Janahi, I, Elhag, W, Alnaama, A, Zainel, A, Hassan, D, Cable, T, Charlson, M, Wells, M, Al-Hamaq, A, Al-Abdulla, S & Abou-Samra, AB 2018, 'Diabetes Intervention Accentuating Diet and Enhancing Metabolism (DIADEM-I): a randomised controlled trial to examine the impact of an intensive lifestyle intervention consisting of a low-energy diet and physical activity on body weight and metabolism in early type 2 diabetes mellitus: study protocol for a randomized controlled trial', Trials, vol. 19, no. 1, 284. https://doi.org/10.1186/s13063-018-2660-1

Diabetes Intervention Accentuating Diet and Enhancing Metabolism (DIADEM-I): a randomised controlled trial to examine the impact of an intensive lifestyle intervention consisting of a low-energy diet and physical activity on body weight and metabolism in early type 2 diabetes mellitus: study protocol for a randomized controlled trial. / Taheri, Shahrad; Chagoury, Odette; Zaghloul, Hadeel et al.
In: Trials, Vol. 19, No. 1, 284, 21.05.2018.

Research output: Contribution to journal › Article › peer-review

TY - JOUR

T1 - Diabetes Intervention Accentuating Diet and Enhancing Metabolism (DIADEM-I)

T2 - a randomised controlled trial to examine the impact of an intensive lifestyle intervention consisting of a low-energy diet and physical activity on body weight and metabolism in early type 2 diabetes mellitus: study protocol for a randomized controlled trial

AU - Taheri, Shahrad

AU - Chagoury, Odette

AU - Zaghloul, Hadeel

AU - Elhadad, Sara

AU - Ahmed, Salma Hayder

AU - Omar, Omar

AU - Payra, Sherryl

AU - Ahmed, Salma

AU - El Khatib, Neda

AU - Amona, Rasha Abou

AU - El Nahas, Katie

AU - Bolton, Matthew

AU - Chaar, Henem

AU - Suleiman, Noor

AU - Jayyousi, Amin

AU - Zirie, Mahmoud

AU - Janahi, Ibrahim

AU - Elhag, Wahiba

AU - Alnaama, Abdulla

AU - Zainel, Abduljaleel

AU - Hassan, Dahlia

AU - Cable, Tim

AU - Charlson, Mary

AU - Wells, Martin

AU - Al-Hamaq, Abdulla

AU - Al-Abdulla, Samya

AU - Abou-Samra, Abdul Badi

PY - 2018/5/21

Y1 - 2018/5/21

N2 - BACKGROUND: Type 2 diabetes mellitus (T2DM) and obesity are syndemic and will have a significant impact on affected individuals and healthcare services worldwide. Evidence shows that T2DM remission can be achieved with significant weight loss in those who are younger with early diabetes and requiring fewer medications for glycaemic control. DIADEM-I aims to examine the impact of an intensive lifestyle intervention (ILI) using a low-energy diet (LED) meal replacement approach combined with physical activity in younger individuals with early T2DM.METHODS: The planned study is an ongoing, non-blinded, pragmatic, randomised controlled, parallel-group trial examining the impact of an LED-based ILI on body weight and diabetes remission in younger (18-50 years) T2DM individuals with early diabetes (≤ 3-year duration). The ILI will be compared to usual medical care (UMC). The primary outcome will be weight loss at 12 months. Other key outcomes of interest include diabetes remission, glycaemic control, diabetes complications, cardiovascular health, physical activity, mental health, and quality of life. It is planned for the study to include 138 subjects for assessment of the primary outcome. Safety will be assessed throughout.DISCUSSION: If DIADEM-I demonstrates a clinically significant effect for younger individuals with early T2DM, it will inform clinical guidelines and services of the future for management of T2DM.TRIAL REGISTRATION: ISRCTN: ISRCTN20754766 (date assigned: 7 June 2017); ClinicalTrials.gov, ID: NCT03225339 Registered on 26 June 2017.

AB - BACKGROUND: Type 2 diabetes mellitus (T2DM) and obesity are syndemic and will have a significant impact on affected individuals and healthcare services worldwide. Evidence shows that T2DM remission can be achieved with significant weight loss in those who are younger with early diabetes and requiring fewer medications for glycaemic control. DIADEM-I aims to examine the impact of an intensive lifestyle intervention (ILI) using a low-energy diet (LED) meal replacement approach combined with physical activity in younger individuals with early T2DM.METHODS: The planned study is an ongoing, non-blinded, pragmatic, randomised controlled, parallel-group trial examining the impact of an LED-based ILI on body weight and diabetes remission in younger (18-50 years) T2DM individuals with early diabetes (≤ 3-year duration). The ILI will be compared to usual medical care (UMC). The primary outcome will be weight loss at 12 months. Other key outcomes of interest include diabetes remission, glycaemic control, diabetes complications, cardiovascular health, physical activity, mental health, and quality of life. It is planned for the study to include 138 subjects for assessment of the primary outcome. Safety will be assessed throughout.DISCUSSION: If DIADEM-I demonstrates a clinically significant effect for younger individuals with early T2DM, it will inform clinical guidelines and services of the future for management of T2DM.TRIAL REGISTRATION: ISRCTN: ISRCTN20754766 (date assigned: 7 June 2017); ClinicalTrials.gov, ID: NCT03225339 Registered on 26 June 2017.

KW - Type 2 diabetes mellitus

KW - Obesity

KW - Lifestyle

KW - Diet

KW - Physical activity

U2 - 10.1186/s13063-018-2660-1

DO - 10.1186/s13063-018-2660-1

M3 - Article

C2 - 29784059

SN - 1745-6215

VL - 19

JO - Trials

JF - Trials

IS - 1

M1 - 284

ER -

Taheri S, Chagoury O, Zaghloul H, Elhadad S, Ahmed SH, Omar O et al. Diabetes Intervention Accentuating Diet and Enhancing Metabolism (DIADEM-I): a randomised controlled trial to examine the impact of an intensive lifestyle intervention consisting of a low-energy diet and physical activity on body weight and metabolism in early type 2 diabetes mellitus: study protocol for a randomized controlled trial. Trials. 2018 May 21;19(1):284. doi: 10.1186/s13063-018-2660-1