Clinical trial NCT03503942: The Pre-Diabetes Interventions and Continued Tracking to Ease-out Diabetes (Pre-DICTED) Program
Official title: The Pre-Diabetes Interventions and Continued Tracking to Ease-out Diabetes (Pre-DICTED) Program
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pre-diabetes
Lead sponsor: Singapore General Hospital
Sponsor class: OTHER
Collaborators: name: Ministry of Health, Singapore
name: Health Promotion Board, Singapore
name: Singapore Clinical Research Institute
name: Duke-NUS Graduate Medical School
First posted: 2018-04-20
Enrollment: 751
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The Pre-DICTED (Pre-Diabetes Intervention and Continued Tracking to Ease-out Diabetes) program is a community-based diabetes prevention program. This study aims to test the effectiveness of structured, group-based lifestyle interventions with stepwise addition of metformin, if required, among subjects with pre-diabetes in multi-ethnic Singapore.

Detailed description: The Pre-DICTED program is designed as a randomized, controlled, pragmatic trial. The program targets to recruit up to 846 overweight/obese (BMI ≥23.0) adults (age 18-64) with isolated impaired fasting glucose (IFG), isolated impaired glucose tolerance (IGT), or IFG + IGT in Singapore. The follow-up period will be 3 years.

Eligible subjects will be identified through community, primary care clinics and hospital-based diabetes screening program. Following informed consent, eligible participants will be randomised into the control or the treatment arm.

Participants in the control arm will receive the current standard of care for pre-diabetes which includes counseling on lifestyle modifications and follow up by primary care physicians.

Participants in the treatment arm will undergo a 3-month, locally tailored, group-based lifestyle intervention program (consisting of nutrition workshops, exercise sessions and goal-setting workshop) plus subsequent stepwise addition of metformin for selected participants at the highest risk of progression to diabetes at ≥ 6 months of follow-up. Financial incentives will be awarded to participants who achieve weight lost of ≥5% of baseline weight during follow-up period.

The primary outcome of diabetes incidence will be assessed bi-annually and compared across the study arms. Secondary outcomes will include weight, waist circumference, fasting plasma glucose (FPG), 2-h glucose, HbA1c, physical activity, diet and metformin adherence.

Eligibility criteria: Inclusion Criteria:

1. Singapore citizens or permanent residents
2. Age between 18 and 64
3. Body mass index (BMI) ≥ 23.0 kg/m2
4. Pre-diabetes diagnosed based on:

   1. fasting plasma glucose 6.1 - 6.9 mmol/L (Impaired fasting glucose; IFG) and/or
   2. 2-hr plasma glucose in 75g oral glucose tolerance test (OGTT) 7.8 - 11.0 mmol/L (Impaired glucose tolerance; IGT) (Laboratory tests to be done within 6 months of enrolment)

Exclusion Criteria:

1. Individuals with diabetes mellitus
2. Health conditions impeding participation in lifestyle change programme (e.g. active cancer, recent myocardial event within 6 months, heart failure, chronic kidney disease)
3. Current pregnancy or breast feeding
4. Treatment with medications known to alter glucose tolerance
5. Known allergic reaction to metformin

Primary outcomes:
measure: Diabetes incidence
timeFrame: 3 years
Secondary outcomes:
measure: Weight
timeFrame: 3 years
measure: Waist circumference
timeFrame: 3 years
measure: HbA1c
timeFrame: 3 years
measure: Fasting plasma glucose
timeFrame: 3 years
measure: 2-hour plasma glucose
timeFrame: 3 years
measure: International physical activity questionnaire (IPAQ) score
timeFrame: 3 years
measure: Metformin adherence
timeFrame: Up to 30 months
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Singapore General Hospital
Study officials:
affiliation: Singapore General Hospital
name: Yong Mong Bee
role: PRINCIPAL_INVESTIGATOR
References:
citation: Yeung KF, Gandhi M, Lam AYR, Julianty S, Chia AYM, Tan GCS, Goh SY, Ho ETL, Koh AFY, Tan GSW, Shum EJW, Finkelstein EA, Jafar TH, Teoh YL, van Dam RM, Whitton C, Thumboo J, Bee YM. The Pre-Diabetes Interventions and Continued Tracking to Ease-out Diabetes (Pre-DICTED) program: study protocol for a randomized controlled trial. Trials. 2021 Aug 6;22(1):522. doi: 10.1186/s13063-021-05500-5.