Implementation of a Very Low Calorie Diet for Remission of Type 2 Diabetes in the Community

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03536377
• Date of registration: 14/05/2018
• Prospective Registration: Yes
• Primary sponsor: The University of The West Indies
• Public title: Implementation of a Very Low Calorie Diet for Remission of Type 2 Diabetes in the Community
• Scientific title: Implementation of a Very Low Calorie Diet for Remission of Type 2 Diabetes in the Community
• Date of first enrolment: February 11, 2019
• Target sample size: 100
• Recruitment status: Unknown status
• URL: https://clinicaltrials.gov/show/NCT03536377
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

Barbados

Contacts

• Name: T Alafia Samuels, MBBS, PhD
• Affiliation: George Alleyne Chronic Disease Research Centre, The University of the West Indies

• Name: Kim R Quimby, MBBS, PhD

Key inclusion & exclusion criteria

Inclusion Criteria:

- Adults aged 20 - 70 years old, all ethnicities

- Diagnosis of T2DM for <6 years as defined by the American Diabetes Association

- Diagnosis of pre-diabetes as defined by the American Diabetes Association

- Body Mass index (BMI) of 27 kg/m2 and over

Exclusion Criteria:

- Insulin use

- Substance abuse

- Current cancer diagnosis

- myocardial infarction within last 6 month

- learning difficulties

- current treatment with anti-obesity drugs

- diagnosed eating disorder or purging

- HbA1c > 10%

- pregnant/considering pregnancy

- evidence of liver disease (including liver enzymes > 3 times above normal values)

- evidence of renal disease (creatinine of > 150 mmol/l)

- persons who have required hospitalisation for depression, or are on antipsychotic
drugs



Age minimum: 20 Years
Age maximum: 70 Years
Gender: All

Health Condition(s) or Problem(s) studied

Diabetes Mellitus Type 2 in Obese

Intervention(s)

Other: very low calorie liquid diet

Primary Outcome(s)

change in fasting glucose [Time Frame: Enrolment, 12 weeks, 6 months, 1 year]

change in Hba1C [Time Frame: Enrolment, 12 weeks, 6 months, 1 year]

change in weight [Time Frame: enrolment, 12 weeks, 6 mths and 1 year]

Secondary Outcome(s)

change in waist circumference [Time Frame: Enrolment, 12 weeks, 6 months, 1 year]

change in blood pressure medication [Time Frame: weekly for the first 12 weeks]

change in blood pressure [Time Frame: Enrolment, 12 weeks, 6 months, 1 year]

Secondary ID(s)

BDRS2

Source(s) of Monetary Support

Please refer to primary and secondary sponsors