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.

Conditions

Type 2 Diabetes Mellitus Nutritional, Metabolic, Endocrine Type 2 Diabetes Mellitus

Hadeel Zaghloul, Odette Chagoury, Sara Elhadad, Salma Ahmed, Noor Suleiman et al. (13 authors)

BMJ Open2020-12-018 citations

10.1136/bmjopen-2020-041386

Effect of intensive lifestyle intervention on bodyweight and glycaemia in early type 2 diabetes (DIADEM-I): an open-label, parallel-group, randomised controlled trial.

Taheri S, Zaghloul H, Chagoury O, Elhadad S, Ahmed SH, El Khatib N, Amona RA, El Nahas K, Suleiman N, Alnaama A, Al-Hamaq A, Charlson M, Wells MT, Al-Abdulla S, Abou-Samra AB.

2020-06-01254 citations

10.1016/s2213-8587(20)30117-0

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 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.

2018-05-2112 citations

10.1186/s13063-018-2660-1

Interventions

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 i

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

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 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

Design outcomes

Primary

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

Secondary

Measure	Time frame
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	—

Measure

Time frame

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

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Countries

Qatar

Contacts

Public ContactShahrad Taheri

szt2004@qatar-med.cornell.edu+974 4492 8470

Outcome results

None listed