Diabetes Intervention Accentuating Diet and Enhancing Metabolism

NCT ID: NCT03225339

Last Updated: 2021-04-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 209 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-07-16
• Study Completion Date: 2020-12-09

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.

Conditions

Diabetes Mellitus, Type 2

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Lifestyle Intervention

The intervention includes the use of Low Energy Diet replacement products in combination with physical activity, followed by gradual introduction of food, and increasing physical activity. Behavioural support for the lifestyle intervention will also be provided.

Group Type: EXPERIMENTAL

Low Energy Diet

Intervention Type: DIETARY_SUPPLEMENT

Low Energy Diet

Usual Care

This will be based on current clinical practice aiming to reduce diabetes symptoms and complications, and general recommendations on diet and physical activity.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Low Energy Diet

Low Energy Diet

Intervention Type: DIETARY_SUPPLEMENT

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hamad Medical Corporation

INDUSTRY

Sponsor Role: collaborator

Weill Medical College of Cornell University

OTHER

Sponsor Role: collaborator

Cornell University

OTHER

Sponsor Role: collaborator

Weill Cornell Medical College in Qatar

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Shahrad Taheri, MB BS PhD

Role: PRINCIPAL_INVESTIGATOR

Weill Cornell Medicine - Qatar

Locations

Primary Healthcare Corporation

Doha, , Qatar

Hamad Medical Corporation

Doha, , Qatar

Countries

Qatar

References

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.

Reference Type: BACKGROUND

PMID: 29784059 (View on PubMed)

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.

Reference Type: RESULT

PMID: 32445735 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 33293319 (View on PubMed)

Other Identifiers

15-00071

Identifier Type: -

Identifier Source: org_study_id