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

Primary Purpose

Diabetes Mellitus, Type 2

Status
Completed
Phase
Not Applicable
Locations
Qatar
Study Type
Interventional
Intervention
Low Energy Diet
Sponsored by
Weill Cornell Medical College in Qatar
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 2

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept 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.

Sites / Locations

  • Primary Healthcare Corporation
  • Hamad Medical Corporation

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Lifestyle Intervention

Usual Care

Arm Description

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.

This will be based on current clinical practice aiming to reduce diabetes symptoms and complications, and general recommendations on diet and physical activity.

Outcomes

Primary Outcome Measures

Weight loss
Weight change (weight in kilograms)

Secondary Outcome Measures

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

Full Information

First Posted
June 12, 2017
Last Updated
April 6, 2021
Sponsor
Weill Cornell Medical College in Qatar
Collaborators
Hamad Medical Corporation, Weill Medical College of Cornell University, Cornell University
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1. Study Identification

Unique Protocol Identification Number
NCT03225339
Brief Title
Diabetes Intervention Accentuating Diet and Enhancing Metabolism
Acronym
DIADEM-1
Official Title
A Randomised Controlled Trial Assessing the Impact of Low Calorie Diet and Activity on Body Weight and Glycaemia in Diabetes
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
July 16, 2017 (Actual)
Primary Completion Date
February 19, 2020 (Actual)
Study Completion Date
December 9, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Weill Cornell Medical College in Qatar
Collaborators
Hamad Medical Corporation, Weill Medical College of Cornell University, Cornell University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
All analyses conducted will be blinded.
Allocation
Randomized
Enrollment
209 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lifestyle Intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Usual Care
Arm Type
No Intervention
Arm Description
This will be based on current clinical practice aiming to reduce diabetes symptoms and complications, and general recommendations on diet and physical activity.
Intervention Type
Dietary Supplement
Intervention Name(s)
Low Energy Diet
Intervention Description
Low Energy Diet
Primary Outcome Measure Information:
Title
Weight loss
Description
Weight change (weight in kilograms)
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Glycaemic control
Description
HbA1c measured biochemically (percentage units)
Time Frame
12 months
Title
Patient reported outcomes
Description
Euro-QoL-5D
Time Frame
12 months
Other Pre-specified Outcome Measures:
Title
Insulin sensitivity/resistance
Description
Fasting Insulin and Glucose levels will be combined to calculate: Homeostatic model assessment (HOMA-IR)
Time Frame
12 months
Title
Body Mass Index
Description
Weight and height measures will be used to calculate body mass index: Weight(kg)/(height[m])2
Time Frame
12 months
Title
Waist Circumference
Description
Waist Circumference measured in cm
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shahrad Taheri, MB BS PhD
Organizational Affiliation
Weill Cornell Medicine - Qatar
Official's Role
Principal Investigator
Facility Information:
Facility Name
Primary Healthcare Corporation
City
Doha
ZIP/Postal Code
P.O. Box 26555
Country
Qatar
Facility Name
Hamad Medical Corporation
City
Doha
ZIP/Postal Code
PO Box 3050
Country
Qatar

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Data will be available from the Principal Investigator.
IPD Sharing Time Frame
2022-2024
IPD Sharing Access Criteria
Access requests to be made to the Principal Investigator.
Citations:
PubMed Identifier
29784059
Citation
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.
Results Reference
background
PubMed Identifier
32445735
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 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.
Results Reference
result
PubMed Identifier
33293319
Citation
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.
Results Reference
derived

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Diabetes Intervention Accentuating Diet and Enhancing Metabolism

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