Status:
COMPLETED
Ectopic Fat in Singaporean Women - the Culprit Leading to Gestational Diabetes, Metabolic Syndrome, and Type 2 Diabetes (TANGO Study)
Lead Sponsor:
Institute for Human Development and Potential (IHDP), Singapore
Collaborating Sponsors:
Wilmar International Limited
SATA CommHealth (Singapore)
Conditions:
Non-Alcoholic Fatty Liver Disease
Eligibility:
FEMALE
21-45 years
Phase:
NA
Brief Summary
Ectopic fat is the accumulation of adipose tissue in anatomical sites not classically associated with fat storage - for example, in the liver and skeletal muscles. Excessive fat accumulation in liver ...
Detailed Description
The study will consist of a 12-week, parallel three-arm, single-centre, randomized controlled trial (RCT); 90 women of Chinese ethnicity matched for age and BMI will be randomized to one of 3 study ar...
Eligibility Criteria
Inclusion
- Chinese ethnicity
- Females, Age 21-45 years
- Body mass index (BMI) 23-35 kg/m2
- Not planning to conceive within 6 months from enrolment
- Elevated liver fat content (FibroScan CAP score \>=268 dB/m)
Exclusion
- Do not intend to reside in Singapore for the next 6 months
- Delivered within the last 6 months
- Currently pregnant or breastfeeding
- Having more than 5% weight loss over the past 3 months
- Receiving antibiotics or suffering from diarrhoea over the last 3 months
- Not willing to adhere to lifestyle intervention required by study
- Following special diets or having intentional dietary restrictions (e.g. vegetarians/vegans/ketogenic diet)
- Having contraindications for MRI e.g. metallic implants such as cardiac pacemaker
- Having alcohol consumption on more than 4 days per week with 6 or more alcoholic drinks per week
- Current and/or history of diabetes mellitus, other than GDM (Gestational Diabetes Mellitus)
- Having chronic medical conditions such as cancer, severe gastrointestinal disorders, infectious diseases such as hepatitis and severe mental disorders
- Having uncontrolled hypertension (\> 150/90 mmHg)
- Having any medication and/or supplements which may interfere with study results
- Having allergies or intolerances to any common food ingredients including eggs, fish, milk, sesame, mustard, sulphites, peanuts and tree nuts, shellfish, soy, wheat, gluten, cereal, fruits, dairy products, meat, vegetable, sugar and sweetener, food colourings or flavourings, etc.
Key Trial Info
Start Date :
August 20 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 31 2022
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT05259475
Start Date
August 20 2021
End Date
July 31 2022
Last Update
September 25 2023
Active Locations (1)
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1
Human Development Research Centre (Hdrc)
Singapore, Singapore, 117597