NCT05762120

Brief Summary

The goal of this clinical trial is to determine the effectiveness of a weight management programme in primary care in achieving diabetes remission in obese patients with early diabetes. Potential participants are to attend a screening visit to determine eligibility. Eligible participants will be invited to participate in the trial within 3 months of screening visit. 120 participants will be recruited into the study and randomised into 2 arms: control group (60 participants) or intervention group (60 participants). Control group: Participants randomised to the control group will receive usual care with their healthcare team. Intervention group: Participants randomised to the intervention group will be put on a weight management programme with the aim of achieving weight loss of at least 15% body weight or 15kg. Researchers will compare between control and intervention groups to see if a weight management programme is effective in achieving diabetes remission in obese patients with early diabetes, compared to usual care.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for not_applicable diabetes-mellitus-type-2

Timeline
Completed

Started Feb 2023

Typical duration for not_applicable diabetes-mellitus-type-2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 3, 2023

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

February 27, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 9, 2023

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2025

Completed
Last Updated

March 15, 2023

Status Verified

March 1, 2023

Enrollment Period

1.8 years

First QC Date

February 27, 2023

Last Update Submit

March 13, 2023

Conditions

Diabetes Mellitus, Type 2Obesity

Outcome Measures

Primary Outcomes (2)

  • Diabetes Remission

    Percentage of participants achieving HbA1c \<6.5% without medications

    12 months (52 weeks)

  • Weight Loss

    Percentage of participants achieving weight loss of 15% or 15kg or more

    12 months (52 weeks)

Study Arms (2)

Control

NO INTERVENTION

Usual Care

Intervention

OTHER

Weight Management Programme

Other: Weight Management Programme

Interventions

Weight Management ProgrammeOTHER

Weight Management Programme which consists of 4 phases: 1. Very low calorie diet 2. Low calorie diet 3. Maintenance phase 4. Continuance phase

Intervention

Eligibility Criteria

Age21 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Singaporean citizen or Singaporean Permanent Resident
  • Age between 21 to 60 years old
  • BMI between 27 to 45kg/m2
  • Type 2 Diabetes Mellitus diagnosis of less than 5 years duration
  • Recent HbA1c more than or equals to 6.5% if patient is on diet management alone
  • Recent HbA1c more than or equals to 6.1% if patient is on treatment with oral hypoglycaemic agents
  • Able to consume food products containing fish oil
  • Able to consume dairy products
  • Able to commit to study duration

You may not qualify if:

  • Current insulin use
  • Current treatment with anti-obesity drugs
  • Recent HbA1c more than or equals to 12%
  • Recent eGFR \< 60 mL/min/1.73m2
  • History of diabetic retinopathy
  • History of ischaemic heart disease, myocardial infarction or cardiac failure
  • History of cerebrovascular event
  • Known liver cirrhosis
  • Known cancer not in remission
  • Active gout
  • Active gallstone disease or known asymptomatic gallstones
  • History of diagnosed eating disorder
  • History of hospitalisation for depression or on antidepressants within the past 6 months
  • Significant previously diagnosed psychiatric disorder eg schizophrenia, obsessive compulsive disorder
  • History of substance abuse, including alcohol use disorder
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Healthcare Group Polyclinics

Singapore, 138543, Singapore

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Obesity

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesOverweightOvernutritionNutrition DisordersBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Wern Ee Tang

    National Healthcare Group Polyclinics

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Wern Ee Tang

CONTACT

(65) 63553000wern_ee_tang@nhgp.com.sg

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, Clinical Research Unit and Information Management and Analytics

Study Record Dates

First Submitted

February 27, 2023

First Posted

March 9, 2023

Study Start

February 3, 2023

Primary Completion

December 1, 2024

Study Completion

March 1, 2025

Last Updated

March 15, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations

SG(1)