Diabetes Intervention Accentuating Diet and Enhancing Metabolism (DIADEM-1)

A Randomised Controlled Trial Assessing the Impact of Low Calorie Diet and Activity on Body Weight and Glycaemia in Diabetes

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.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus, Type 2
• Intervention / Treatment: Dietary supplement: Low Energy Diet

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.

• Study Type: Interventional
• Enrollment (Actual): 209
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Qatar
  • Doha, Qatar, P.O. Box 26555
    • Primary Healthcare Corporation
  • Doha, Qatar, PO Box 3050
    • Hamad medical corporation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Dietary supplement: Low Energy Diet; Low Energy Diet
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Weight loss	Weight change (weight in kilograms)	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Glycaemic control	HbA1c measured biochemically (percentage units)	12 months
Patient reported outcomes	Euro-QoL-5D	12 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Insulin sensitivity/resistance	Fasting Insulin and Glucose levels will be combined to calculate: Homeostatic model assessment (HOMA-IR)	12 months
Body Mass Index	Weight and height measures will be used to calculate body mass index: Weight(kg)/(height[m])2	12 months
Waist Circumference	Waist Circumference measured in cm	12 months

Collaborators and Investigators

• Sponsor: Weill Cornell Medical College in Qatar
• Collaborators: Weill Medical College of Cornell University; Hamad Medical Corporation; Cornell University
• Investigators: Principal Investigator: Shahrad Taheri, MB BS PhD, Weill Cornell Medicine - Qatar

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): July 16, 2017
• Primary Completion (Actual): February 19, 2020
• Study Completion (Actual): December 9, 2020

Study Registration Dates

• First Submitted: June 12, 2017
• First Submitted That Met QC Criteria: July 20, 2017
• First Posted (Actual): July 21, 2017

Study Record Updates

• Last Update Posted (Actual): April 8, 2021
• Last Update Submitted That Met QC Criteria: April 6, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: 15-00071

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Data will be available from the Principal Investigator.
• IPD Sharing Time Frame: 2022-2024
• IPD Sharing Access Criteria: Access requests to be made to the Principal Investigator.
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No