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. 2018 May 21;19(1):284.
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  1   2   3   4   5 , Odette Chagoury  6   7   8 , Hadeel Zaghloul  6   7   8 , Sara Elhadad  8 , Salma Hayder Ahmed  8 , Omar Omar  8 , Sherryl Payra  8 , Salma Ahmed  8 , Neda El Khatib  9 , Rasha Abou Amona  9 , Katie El Nahas  9 , Matthew Bolton  8 , Henem Chaar  8 , Noor Suleiman  10 , Amin Jayyousi  10 , Mahmoud Zirie  10 , Ibrahim Janahi  10 , Wahiba Elhag  11 , Abdulla Alnaama  12 , Abduljaleel Zainel  12 , Dahlia Hassan  12 , Tim Cable  13 , Mary Charlson  7 , Martin Wells  14 , Abdulla Al-Hamaq  9 , Samya Al-Abdulla  12 , Abdul Badi Abou-Samra  6   11   10
Affiliations

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 et al. Trials. .

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: Diet; Lifestyle; Obesity; Physical activity; Type 2 diabetes mellitus.

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Conflict of interest statement

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.

Figures

Fig. 1
Fig. 1
CONSORT flow chart for DIADEM-I Study. LED = Low Energy Diet; PA = Physical Activity
Fig. 2
Fig. 2
Schedule of enrolment, intervention, study visits and assessments for both study groups
See this image and copyright information in PMC

References

    1. Araghi MH, Chen YF, Jagielski A, Choudhury S, Banerjee D, Hussain S, et al. Effectiveness of lifestyle interventions on obstructive sleep apnea (OSA): systematic review and meta-analysis. Sleep. 2013;36:1553–1562. doi: 10.5665/sleep.3056. - DOI - PMC - PubMed
    1. Grover SA, Kaouache M, Rempel P, Joseph L, Dawes M, Lau DCW, et al. Years of life lost and healthy life-years lost from diabetes and cardiovascular disease in overweight and obese people: a modelling study. Lancet Diab Endocrinol. 2015;3(2):114–22. 10.1016/S2213-8587(14)70229-3. - PubMed
    1. Young T, Peppard PE, Taheri S. Excess weight and sleep-disordered breathing. J Appl Physiol. 2005;99:1592–1599. doi: 10.1152/japplphysiol.00587.2005. - DOI - PubMed
    1. Jagielski AC, Brown A, Hosseini-Araghi M, Thomas GN, Taheri S. The association between adiposity, mental well-being, and quality of life in extreme obesity. PLoS One. 2014;9:e92859. doi: 10.1371/journal.pone.0092859. - DOI - PMC - PubMed
    1. Dhanda N, Taheri S. A narrative review of obesity and hearing loss. Int J Obes. 2017;41:1066–1073. doi: 10.1038/ijo.2017.32. - DOI - PubMed

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