Diabetes Intervention Accentuating Diet and Enhancing Metabolism

Conditions

Diabetes Mellitus, Type 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.

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.

Hadeel Zaghloul, Odette Chagoury, Sara Elhadad, Salma Ahmed, Noor Suleiman et al. (13 authors)

BMJ Open2020-12-018 citations

10.1136/bmjopen-2020-041386

Effect of intensive lifestyle intervention on bodyweight and glycaemia in early type 2 diabetes (DIADEM-I): an open-label, parallel-group, randomised controlled trial.

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.

2020-06-01254 citations

10.1016/s2213-8587(20)30117-0

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.

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.

2018-05-2112 citations

10.1186/s13063-018-2660-1

Interventions

DIETARY_SUPPLEMENTLow Energy Diet

Low Energy Diet

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Masking description

All analyses conducted will be blinded.

Eligibility

Sex/Gender

ALL

Age

18 Years to 50 Years

Healthy volunteers

No

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.

Design outcomes

Primary

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

Secondary

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

Other

Measure	Time frame	Description
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

Countries

Qatar

Outcome results

None listed