CClinicalTrials.gg
Sign In
CompletedNCT03225339DIADEM-1Updated Apr 8, 2021

Diabetes Intervention Accentuating Diet and Enhancing Metabolism

An interventional study of Low Energy Diet in Diabetes Mellitus, Type 2, sponsored by Weill Cornell Medical College in Qatar. Completed at 2 sites in Qatar. Open to participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2021-04-08.

Sponsored by Weill Cornell Medical College in Qatar · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
209
Allocation
Randomized
Ages
18 Years to 50 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Diabetes Mellitus, Type 2
03

In context

Diabetes Mellitus

10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.

This study's enrollment of 209 is above the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.

Browse Diabetes Mellitus studies →

Lead sponsor

Weill Cornell Medical College in Qatar is the lead sponsor of 12 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
All
Accepts 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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
209 participants (actual)

Study arms

  • 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

  • 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.

Interventions

  • Dietary supplementLow Energy Diet

    Low Energy Diet

06

What researchers measure

Primary outcomes

  1. Weight loss

    Weight change (weight in kilograms)

    Time frame: 12 months

Secondary outcomes

  1. Glycaemic control

    HbA1c measured biochemically (percentage units)

    Time frame: 12 months

  2. Patient reported outcomes

    Euro-QoL-5D

    Time frame: 12 months

Other outcomes

  1. Insulin sensitivity/resistance

    Fasting Insulin and Glucose levels will be combined to calculate: Homeostatic model assessment (HOMA-IR)

    Time frame: 12 months

  2. Body Mass Index

    Weight and height measures will be used to calculate body mass index: Weight(kg)/(height\[m\])2

    Time frame: 12 months

  3. Waist Circumference

    Waist Circumference measured in cm

    Time frame: 12 months

07

Study locations

2 sites
  • Primary Healthcare Corporation
    Doha, P.O. Box 26555, Qatar
  • Hamad Medical Corporation
    Doha, PO Box 3050, Qatar
08

References and documents

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. PubMed 29784059 ↗
  • 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. PubMed 32445735 ↗
  • 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. PubMed 33293319 ↗

Individual participant data

Plan to share: Yes — Data will be available from the Principal Investigator.

Supporting information: Study protocol, Sap, Icf

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 8, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03225339
Lead sponsor
Weill Cornell Medical College in Qatar
Collaborators
Hamad Medical Corporation, Weill Medical College of Cornell University, Cornell University
Responsible party
Sponsor
First posted
Jul 21, 2017
Start date
Jul 16, 2017
Primary completion
Feb 19, 2020
Completion
Dec 9, 2020
Last update
Apr 8, 2021

Study contacts

Shahrad Taheri, MB BS PhD
principal investigator · Weill Cornell Medicine - Qatar

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2021. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Diabetes Mellitus→

Other studies from this sponsor

Weill Cornell Medical College in Qatar

Start the discussion