Diabetes Intervention Accentuating Diet and Enhancing Metabolism

Diabetes Mellitus, Type 2 Clinical Trial

— DIADEM-1  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03225339
• Other study ID #: 15-00071
• Status: Completed
• Phase: N/A
• Start date: July 16, 2017
• Est. completion date: December 9, 2020

Study information

• Verified date: April 2021
• Source: Weill Cornell Medical College in Qatar
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 209
• Est. completion date: December 9, 2020
• Est. primary completion date: February 19, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Dietary Supplement:
• Low Energy Diet
Low Energy Diet

Locations

Country	Name	City	State
Qatar	Hamad Medical Corporation	Doha
Qatar	Primary Healthcare Corporation	Doha

Sponsors (4)

Lead Sponsor	Collaborator
Weill Cornell Medical College in Qatar	Cornell University, Hamad Medical Corporation, Weill Medical College of Cornell University

Country where clinical trial is conducted

Qatar, 

References & Publications (2)

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. — View 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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Insulin sensitivity/resistance	Fasting Insulin and Glucose levels will be combined to calculate: Homeostatic model assessment (HOMA-IR)	12 months
Other	Body Mass Index	Weight and height measures will be used to calculate body mass index: Weight(kg)/(height[m])2	12 months
Other	Waist Circumference	Waist Circumference measured in cm	12 months
Primary	Weight loss	Weight change (weight in kilograms)	12 months
Secondary	Glycaemic control	HbA1c measured biochemically (percentage units)	12 months
Secondary	Patient reported outcomes	Euro-QoL-5D	12 months