PMID- 29784059
OWN - NLM
STAT- MEDLINE
DCOM- 20190322
LR  - 20191210
IS  - 1745-6215 (Electronic)
IS  - 1745-6215 (Linking)
VI  - 19
IP  - 1
DP  - 2018 May 21
TI  - 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.
PG  - 284
LID - 10.1186/s13063-018-2660-1 [doi]
LID - 284
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.
FAU - Taheri, Shahrad
AU  - Taheri S
AUID- ORCID: 0000-0001-8314-1500
AD  - Department of Medicine, Weill Cornell Medicine - Qatar, Doha, Qatar. 
      staheri@me.com.
AD  - Joan and Sanford I. Weill Department of Medicine, Weill Cornell Medicine - New 
      York, New York, NY, USA. staheri@me.com.
AD  - Clinical Research Core, Weill Cornell Medicine - Qatar, Doha, Qatar. 
      staheri@me.com.
AD  - Qatar Metabolic Institute (QMI), Department of Medicine, Hamad Medical 
      Corporation, Doha, Qatar. staheri@me.com.
AD  - Weill Cornell Medicine - Qatar, Qatar Foundation - Education City, PO 24144, 
      Doha, Qatar. staheri@me.com.
FAU - Chagoury, Odette
AU  - Chagoury O
AD  - Department of Medicine, Weill Cornell Medicine - Qatar, Doha, Qatar.
AD  - Joan and Sanford I. Weill Department of Medicine, Weill Cornell Medicine - New 
      York, New York, NY, USA.
AD  - Clinical Research Core, Weill Cornell Medicine - Qatar, Doha, Qatar.
FAU - Zaghloul, Hadeel
AU  - Zaghloul H
AD  - Department of Medicine, Weill Cornell Medicine - Qatar, Doha, Qatar.
AD  - Joan and Sanford I. Weill Department of Medicine, Weill Cornell Medicine - New 
      York, New York, NY, USA.
AD  - Clinical Research Core, Weill Cornell Medicine - Qatar, Doha, Qatar.
FAU - Elhadad, Sara
AU  - Elhadad S
AD  - Clinical Research Core, Weill Cornell Medicine - Qatar, Doha, Qatar.
FAU - Ahmed, Salma Hayder
AU  - Ahmed SH
AD  - Clinical Research Core, Weill Cornell Medicine - Qatar, Doha, Qatar.
FAU - Omar, Omar
AU  - Omar O
AD  - Clinical Research Core, Weill Cornell Medicine - Qatar, Doha, Qatar.
FAU - Payra, Sherryl
AU  - Payra S
AD  - Clinical Research Core, Weill Cornell Medicine - Qatar, Doha, Qatar.
FAU - Ahmed, Salma
AU  - Ahmed S
AD  - Clinical Research Core, Weill Cornell Medicine - Qatar, Doha, Qatar.
FAU - El Khatib, Neda
AU  - El Khatib N
AD  - Qatar Diabetes Association, Qatar Foundation, Doha, Qatar.
FAU - Amona, Rasha Abou
AU  - Amona RA
AD  - Qatar Diabetes Association, Qatar Foundation, Doha, Qatar.
FAU - El Nahas, Katie
AU  - El Nahas K
AD  - Qatar Diabetes Association, Qatar Foundation, Doha, Qatar.
FAU - Bolton, Matthew
AU  - Bolton M
AD  - Clinical Research Core, Weill Cornell Medicine - Qatar, Doha, Qatar.
FAU - Chaar, Henem
AU  - Chaar H
AD  - Clinical Research Core, Weill Cornell Medicine - Qatar, Doha, Qatar.
FAU - Suleiman, Noor
AU  - Suleiman N
AD  - Department of Diabetes and Endocrinology, Hamad Medical Corporation, Doha, Qatar.
FAU - Jayyousi, Amin
AU  - Jayyousi A
AD  - Department of Diabetes and Endocrinology, Hamad Medical Corporation, Doha, Qatar.
FAU - Zirie, Mahmoud
AU  - Zirie M
AD  - Department of Diabetes and Endocrinology, Hamad Medical Corporation, Doha, Qatar.
FAU - Janahi, Ibrahim
AU  - Janahi I
AD  - Department of Diabetes and Endocrinology, Hamad Medical Corporation, Doha, Qatar.
FAU - Elhag, Wahiba
AU  - Elhag W
AD  - Qatar Metabolic Institute (QMI), Department of Medicine, Hamad Medical 
      Corporation, Doha, Qatar.
FAU - Alnaama, Abdulla
AU  - Alnaama A
AD  - Primary Health Care Corporation, Doha, Qatar.
FAU - Zainel, Abduljaleel
AU  - Zainel A
AD  - Primary Health Care Corporation, Doha, Qatar.
FAU - Hassan, Dahlia
AU  - Hassan D
AD  - Primary Health Care Corporation, Doha, Qatar.
FAU - Cable, Tim
AU  - Cable T
AD  - Aspire Academy, Doha, Qatar.
FAU - Charlson, Mary
AU  - Charlson M
AD  - Joan and Sanford I. Weill Department of Medicine, Weill Cornell Medicine - New 
      York, New York, NY, USA.
FAU - Wells, Martin
AU  - Wells M
AD  - Department of Statistical Science, Cornell University, Ithaca, NY, USA.
FAU - Al-Hamaq, Abdulla
AU  - Al-Hamaq A
AD  - Qatar Diabetes Association, Qatar Foundation, Doha, Qatar.
FAU - Al-Abdulla, Samya
AU  - Al-Abdulla S
AD  - Primary Health Care Corporation, Doha, Qatar.
FAU - Abou-Samra, Abdul Badi
AU  - Abou-Samra AB
AD  - Department of Medicine, Weill Cornell Medicine - Qatar, Doha, Qatar.
AD  - Qatar Metabolic Institute (QMI), Department of Medicine, Hamad Medical 
      Corporation, Doha, Qatar.
AD  - Department of Diabetes and Endocrinology, Hamad Medical Corporation, Doha, Qatar.
LA  - eng
SI  - ClinicalTrials.gov/NCT03225339
GR  - NPRP 8-912-3-192/Qatar National Research Fund/
PT  - Clinical Trial Protocol
PT  - Journal Article
DEP - 20180521
PL  - England
TA  - Trials
JT  - Trials
JID - 101263253
SB  - IM
MH  - *Body Weight
MH  - *Caloric Restriction
MH  - Diabetes Mellitus, Type 2/metabolism/*therapy
MH  - *Exercise
MH  - Female
MH  - Humans
MH  - Life Style
MH  - Male
MH  - Outcome Assessment, Health Care
MH  - *Pragmatic Clinical Trials as Topic
PMC - PMC5963071
OTO - NOTNLM
OT  - Diet
OT  - Lifestyle
OT  - Obesity
OT  - Physical activity
OT  - Type 2 diabetes mellitus
COIS- ETHICS APPROVAL AND CONSENT TO PARTICIPATE: Ethical approval for the study has 
      been obtained from the Weill Cornell Medicine - Qatar IRB (Number: 15-00071), 
      Hamad Medical Corporation IRB (Number: 15395/15), and Primary Health Care 
      Corporation IRB (Number: PHCC/IEC/17/02/002). The study has also been approved by 
      the Ministry of Public Health, Qatar. All participants will provide written 
      informed consent. COMPETING INTERESTS: The authors declare that they have no 
      competing interests. PUBLISHER'S NOTE: Springer Nature remains neutral with 
      regard to jurisdictional claims in published maps and institutional affiliations.
EDAT- 2018/05/23 06:00
MHDA- 2019/03/23 06:00
PMCR- 2018/05/21
CRDT- 2018/05/23 06:00
PHST- 2018/01/16 00:00 [received]
PHST- 2018/05/02 00:00 [accepted]
PHST- 2018/05/23 06:00 [entrez]
PHST- 2018/05/23 06:00 [pubmed]
PHST- 2019/03/23 06:00 [medline]
PHST- 2018/05/21 00:00 [pmc-release]
AID - 10.1186/s13063-018-2660-1 [pii]
AID - 2660 [pii]
AID - 10.1186/s13063-018-2660-1 [doi]
PST - epublish
SO  - Trials. 2018 May 21;19(1):284. doi: 10.1186/s13063-018-2660-1.