Diabetes Intervention Accentuating Diet and Enhancing Metabolism

NCT03225339 | Completed DMC

• 1 other identifier: 15-00071
• Study Type: interventional
• Target: 209
• Locations: 1 country
• Sites: 2

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.

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

• Weight loss

  Weight change (weight in kilograms)

  12 months

Secondary Outcomes (2)

• Glycaemic control

  12 months

• Patient reported outcomes

  12 months

Other Outcomes (3)

• Insulin sensitivity/resistance

  12 months

• Body Mass Index

  12 months

• Waist Circumference

  12 months

Study Arms (2)

Lifestyle Intervention

EXPERIMENTAL

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.

Dietary Supplement: Low Energy Diet

Usual Care

NO INTERVENTION

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

Interventions

Low Energy Diet DIETARY_SUPPLEMENT

Low Energy Diet

Lifestyle Intervention

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Weill Cornell Medical College in Qatar: lead
• Hamad Medical Corporation: collaborator
• Weill Medical College of Cornell University: collaborator
• Cornell University: collaborator

Study Sites (2)

Primary Healthcare Corporation

Doha, P.O. Box 26555, Qatar

Location

Hamad Medical Corporation

Doha, PO Box 3050, Qatar

Location

Related Publications (3)

• 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.

  PMID: 29784059 BACKGROUND

• 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.

  PMID: 32445735 RESULT

• 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.

  PMID: 33293319 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Caloric Restriction

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Diet Therapy; Nutrition Therapy; Therapeutics; Energy Intake; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Shahrad Taheri, MB BS PhD

  Weill Cornell Medicine - Qatar

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: All analyses conducted will be blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 12, 2017
• First Posted: July 21, 2017
• Study Start: July 16, 2017
• Primary Completion: February 19, 2020
• Study Completion: December 9, 2020
• Last Updated: April 8, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: 2022-2024
• Access Criteria: Access requests to be made to the Principal Investigator.

Locations

QA (2)