Diabetes Intervention Accentuating Diet and Enhancing Metabolism

• Register: ClinicalTrials.gov
• Last refreshed on: 19 April 2021
• Main ID: NCT03225339
• Date of registration: 12/06/2017
• Prospective Registration: Yes
• Primary sponsor: Weill Cornell Medical College in Qatar
• Public title: Diabetes Intervention Accentuating Diet and Enhancing Metabolism DIADEM-1
• Scientific title: A Randomised Controlled Trial Assessing the Impact of Low Calorie Diet and Activity on Body Weight and Glycaemia in Diabetes
• Date of first enrolment: July 16, 2017
• Target sample size: 209
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03225339
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Single (Outcomes Assessor).
• Phase: N/A

Countries of recruitment

Qatar

Contacts

• Name: Shahrad Taheri, MB BS PhD
• Affiliation: Weill Cornell Medicine - Qatar

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: 50 Years
Gender: All

Health Condition(s) or Problem(s) studied

Diabetes Mellitus, Type 2

Intervention(s)

Dietary Supplement: Low Energy Diet

Primary Outcome(s)

Weight loss [Time Frame: 12 months]

Secondary Outcome(s)

Patient reported outcomes [Time Frame: 12 months]

Glycaemic control [Time Frame: 12 months]

Secondary ID(s)

15-00071

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Hamad Medical Corporation

Cornell University

Weill Medical College of Cornell University