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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03225339
Recruitment Status : Active, not recruiting
First Posted : July 21, 2017
Last Update Posted : July 27, 2020
Sponsor:
Collaborators:
Hamad Medical Corporation
Weill Medical College of Cornell University
Cornell University
Information provided by (Responsible Party):
Weill Cornell Medical College in Qatar

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 Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
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 : July 16, 2017
Actual Primary Completion Date : February 19, 2020
Estimated Study Completion Date : February 18, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Body Weight

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.



Primary Outcome Measures :
  1. Weight loss [ Time Frame: 12 months ]
    Weight change (weight in kilograms)


Secondary Outcome Measures :
  1. Glycaemic control [ Time Frame: 12 months ]
    HbA1c measured biochemically (percentage units)

  2. Patient reported outcomes [ Time Frame: 12 months ]
    Euro-QoL-5D


Other Outcome Measures:
  1. Insulin sensitivity/resistance [ Time Frame: 12 months ]

    Fasting Insulin and Glucose levels will be combined to calculate:

    Homeostatic model assessment (HOMA-IR)


  2. Body Mass Index [ Time Frame: 12 months ]
    Weight and height measures will be used to calculate body mass index: Weight(kg)/(height[m])2

  3. Waist Circumference [ Time Frame: 12 months ]
    Waist Circumference measured in cm



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03225339


Locations
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Qatar
Primary Healthcare Corporation
Doha, Qatar, P.O. Box 26555
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
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Principal Investigator: Shahrad Taheri, MB BS PhD Weill Cornell Medicine - Qatar
Publications of Results:
Other Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Weill Cornell Medical College in Qatar
ClinicalTrials.gov Identifier: NCT03225339    
Other Study ID Numbers: 15-00071
First Posted: July 21, 2017    Key Record Dates
Last Update Posted: July 27, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Data will be available from the Principal Investigator.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Time Frame: 2022-2024
Access Criteria: Access requests to be made to the Principal Investigator.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases