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Recruiting 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.

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07710274). StuddyBuddy aggregates publicly available trial information.