Clinical trial NCT03225339: Diabetes Intervention Accentuating Diet and Enhancing Metabolism
Official title: A Randomised Controlled Trial Assessing the Impact of Low Calorie Diet and Activity on Body Weight and Glycaemia in Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Weill Cornell Medical College in Qatar
Sponsor class: OTHER
Collaborators: name: Hamad Medical Corporation
name: Weill Medical College of Cornell University
name: Cornell University
First posted: 2017-07-21
Enrollment: 209
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: The aim of the proposed study is to conduct a pragmatic randomised controlled clinical trial randomising young adult patients with obesity and type 2 diabetes to an intervention incorporating a low calorie diet and physical activity or usual care. The investigators hypothesise that patients in the low calorie intervention arm will have greater weight reduction leading to significant improvement in glycaemic control and cardiovascular risk. The primary outcome will be weight loss. The low calorie diet intervention arm is designed to achieve and maintain significant weight loss through decreased calorie intake, increased physical activity, and behaviour change. Usual care will include routine advice about diet and physical activity. Secondary outcomes include diabetes control, body composition, and quality of life.

Eligibility criteria: Inclusion Criteria:

* Type 2 diabetes mellitus (based on ADA diagnostic criteria) ;
* Diabetes of ≤ 3-year duration;
* BMI \>27.0 kg/m² (based on WHO cut-points for ethnicity 119);
* Men and women;
* Age 18-50 years;
* Originating from the Middle East and North Africa region and resident in Qatar;
* Able to commit to the study duration;
* Able to give informed consent and willing to participate in the study.

Exclusion Criteria:

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

Primary outcomes:
measure: Weight loss
timeFrame: 12 months
Secondary outcomes:
measure: Glycaemic control
timeFrame: 12 months
measure: Patient reported outcomes
timeFrame: 12 months
Other outcomes:
measure: Insulin sensitivity/resistance
timeFrame: 12 months
measure: Body Mass Index
timeFrame: 12 months
measure: Waist Circumference
timeFrame: 12 months
Locations:
city: Doha
country: Qatar
facility: Primary Healthcare Corporation
city: Doha
country: Qatar
facility: Hamad Medical Corporation
Study officials:
affiliation: Weill Cornell Medicine - Qatar
name: Shahrad Taheri, MB BS PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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. 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.
citation: 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. Effect of intensive lifestyle intervention on bodyweight and glycaemia in early type 2 diabetes (DIADEM-I): an open-label, parallel-group, randomised controlled trial. Lancet Diabetes Endocrinol. 2020 Jun;8(6):477-489. doi: 10.1016/S2213-8587(20)30117-0.
citation: Zaghloul H, Chagoury O, Elhadad S, Hayder Ahmed S, Suleiman N, Al Naama A, El Nahas K, Al Hamaq A, Charlson M, Wells MT, Al Abdulla S, Abou-Samra AB, Taheri S. Clinical and metabolic characteristics of the Diabetes Intervention Accentuating Diet and Enhancing Metabolism (DIADEM-I) randomised clinical trial cohort. BMJ Open. 2020 Dec 7;10(12):e041386. doi: 10.1136/bmjopen-2020-041386.