DIADEM-1: Diabetes Intervention Accentuating Diet and Enhancing Metabolism

Sponsor

Weill Cornell Medical College in Qatar (Other)

Overall Status

Completed

CT.gov ID

NCT03225339

Collaborator

Hamad Medical Corporation (Industry), Weill Medical College of Cornell University (Other), Cornell University (Other)

209

Enrollment

Locations

Arms

40.8

Actual Duration (Months)

104.5

Patients Per Site

2.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Diabetes Mellitus, Type 2	Dietary Supplement: Low Energy Diet	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

209 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Masking Description:

All analyses conducted will be blinded.

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jul 16, 2017

Actual Primary Completion Date :

Feb 19, 2020

Actual Study Completion Date :

Dec 9, 2020

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Weight loss [12 months]
Weight change (weight in kilograms)

Secondary Outcome Measures

Glycaemic control [12 months]
HbA1c measured biochemically (percentage units)
Patient reported outcomes [12 months]
Euro-QoL-5D

Other Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 50 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Primary Healthcare Corporation	Doha		Qatar	P.O. Box 26555
2	Hamad Medical Corporation	Doha		Qatar	PO Box 3050

Sponsors and Collaborators

Weill Cornell Medical College in Qatar
Hamad Medical Corporation
Weill Medical College of Cornell University
Cornell University

Investigators

Principal Investigator: Shahrad Taheri, MB BS PhD, Weill Cornell Medicine - Qatar

Study Documents (Full-Text)

None provided.

More Information

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.

Responsible Party:

Weill Cornell Medical College in Qatar

ClinicalTrials.gov Identifier:

NCT03225339

Other Study ID Numbers:

15-00071

First Posted:

Jul 21, 2017

Last Update Posted:

Apr 8, 2021

Last Verified:

Apr 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Diabetes Mellitus

Diabetes Mellitus, Type 2

Study Results

No Results Posted as of Apr 8, 2021