The Pre-Diabetes Interventions and Continued Tracking to Ease-out Diabetes (Pre-DICTED) Program

NCT03503942 | Completed DMC

• 1 other identifier: PREDICTED2017
• Study Type: interventional
• Target: 751
• Locations: 1 country
• Sites: 1

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.

Conditions

Pre-diabetes

Outcome Measures

Primary Outcomes (1)

• Diabetes incidence

  The primary outcome, diabetes incidence, will be diagnosed based on a single, annual OGTT or the semi-annual FPG (Fasting plasma glucose) test

  3 years

Secondary Outcomes (7)

• Weight

  3 years

• Waist circumference

  3 years

• HbA1c

  3 years

• Fasting plasma glucose

  3 years

• 2-hour plasma glucose

  3 years

Study Arms (2)

Treatment arm

EXPERIMENTAL

Participants in the treatment arm will receive structured group-based lifestyle interventions with stepwise addition of metformin for selected high-risk participants.

Behavioral: Lifestyle modification; Drug: Metformin; Other: Financial incentives

Control

NO INTERVENTION

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.

Interventions

Lifestyle modification BEHAVIORAL

Participants in the treatment arm will receive structured, locally tailored, group-based lifestyle interventions that consist of a core intervention phase (3 months) and a maintenance phase (33 months). The core intervention phase will consist of twice weekly group sessions on nutrition, exercise and goal-setting within the first 6 weeks followed by 6 weeks of self-directed lifestyle modification. During the maintenance phase, the participants will receive monthly short message service (SMS) on health tips as well as 6 monthly telephone calls from program coordinators.

Treatment arm

Metformin DRUG

Metformin will be will be prescribed to treatment group participants at highest risk of diabetes conversion (i.e.IFG + IGT or IFG + HbA1c ≥6.0%) after at least 6 months of lifestyle interventions at a starting dose of 250 mg twice a day followed by up-titration to 500 mg twice a day after 3 months if the participants do not experience any gastrointestinal side effects.

Treatment arm

Financial incentives OTHER

Participants will be given cash incentives if they meet the weight loss target, which is pre-defined as 5% of baseline weight, at the 3rd, 6th, 12th, 18th, 24th, 30th and 36th month of study period.

Treatment arm

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Singapore citizens or permanent residents
• Age between 18 and 64
• Body mass index (BMI) ≥ 23.0 kg/m2
• Pre-diabetes diagnosed based on:
• fasting plasma glucose 6.1 - 6.9 mmol/L (Impaired fasting glucose; IFG) and/or
• 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)

You may not qualify if:

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

Sponsors & Collaborators

• Singapore General Hospital: lead
• Ministry of Health, Singapore: collaborator
• Health Promotion Board, Singapore: collaborator
• Singapore Clinical Research Institute: collaborator
• Duke-NUS Graduate Medical School: collaborator

Study Sites (1)

Singapore General Hospital

Singapore, 169608, Singapore

Location

Related Publications (1)

• 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.

  PMID: 34362409 DERIVED

MeSH Terms

Conditions

Glucose Intolerance

Interventions

Metformin

Condition Hierarchy (Ancestors)

Hyperglycemia; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals

Study Officials

• Yong Mong Bee

  Singapore General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 13, 2017
• First Posted: April 20, 2018
• Study Start: December 30, 2017
• Primary Completion: March 31, 2024
• Study Completion: April 15, 2024
• Last Updated: April 19, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)