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NCT07710274
Effectiveness of the Personalized Responses & Integrated Systems for Metabolism (PRISM) on Improving Insulin Resistance Among Adults With Metabolic Syndrome: A Pilot Study (PRISM-I)
Conditions: Metabolic Syndrome (MetS)
Sex: All
Ages: 21 Years – 70 Years
Healthy volunteers: No
Phase: NA
Enrollment: 200
Sponsor: National University Health System, Singapore
Location: National University of Singapore Singapore
Summary
The primary objective of the Personalized Responses \& Integrated Systems for Metabolism (PRISM-I) pilot study is to assess the feasibility of conducting a definitive randomized controlled trial evaluating precision lifestyle interventions for improving insulin resistance in adults with metabolic syndrome.
Eligibility Criteria
Inclusion Criteria:
Participants will be included for if they are:
* (1) adults aged 21-70 years old;
* (2) willing and able to comply with using a CGM, smart ring, food logging app
* (3) able to provide written informed consent;
* (4) English-speaking and literate;
* (5) meet the inclusion criteria for metabolic syndrome and insulin resistance.
* The criteria for insulin resistance is HOMA-IR ≥ 2.5.
* The criteria for metabolic syndrome is to have high waist circumference (≥ 80cm for females and ≥ 90cm for males); and any two of the four below:
* (1) raised triglycerides: 1.7 mmol/L or on treatment;
* (2) reduced HDL cholesterol: \< 1.0 mmol/L (40 mg/dL) in men, \< 1.3 mmol/L (50 mg/dL) in women, or on treatment;
* (3) high blood pressure: 130/85 mmHg or on treatment; or
* (4) raised fasting glucose: 5.6 mmol/L (100 mg/dL) or previously diagnosed with T2DM
Exclusion Criteria:
Participants will be excluded from both phases if they are:
* (1) on insulin therapy;
* (2) are pregnant or lactating;
* (3) have a medical condition or are on a treatment that may interfere with study participation or metabolic assessments, as determined by the study investigators;
* (4) currently participating in other lifestyle modification programs.
Source: ClinicalTrials.gov (NCT07710274). StuddyBuddy aggregates publicly available trial information.