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Recruiting
NCT05762120
Effectiveness of a Weight Management Programme on Diabetes Remission in Obese Patients With Early Diabetes
Conditions: Diabetes Mellitus, Type 2, Obesity
Sex: All
Ages: 21 Years – 60 Years
Phase: NA
Enrollment: 120
Sponsor: National Healthcare Group Polyclinics
Location: Singapore
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.
Eligibility Criteria
Inclusion Criteria:Singaporean citizen or Singaporean Permanent ResidentAge between 21 to 60 years oldBMI between 27 to 45kg/m2Type 2 Diabetes Mellitus diagnosis of less than 5 years durationRecent HbA1c more than or equals to 6.5% if patient is on diet management aloneRecent HbA1c more than or equals to 6.1% if patient is on treatment with oral hypoglycaemic agentsAble to consume food products containing fish oilAble to consume dairy productsAble to commit to study durationExclusion Criteria:Current insulin useCurrent treatment with anti-obesity drugsRecent HbA1c more than or equals to 12%Recent eGFR < 60 mL/min/1.73m2History of diabetic retinopathyHistory of ischaemic heart disease, myocardial infarction or cardiac failureHistory of cerebrovascular eventKnown liver cirrhosisKnown cancer not in remissionActive goutActive gallstone disease or known asymptomatic gallstonesHistory of diagnosed eating disorderHistory of hospitalisation for depression or on antidepressants within the past 6 monthsSignificant previously diagnosed psychiatric disorder eg schizophrenia, obsessive compulsive disorderHistory of substance abuse, including alcohol use disorderWomen who are pregnant, or are considering pregnancy within the following 18 monthsWomen who are breastfeeding, or are considering breastfeeding within the following 18 monthsCurrent participation in another research trial
Source: ClinicalTrials.gov (NCT05762120). StuddyBuddy aggregates publicly available trial information.