N/A
N=27
Composition & Function of Sarcoplasmic Reticulum in Persons With the Metabolic Syndrome
Metabolic Syndrome
Bottom Line
View on ClinicalTrials.gov: NCT02122666 ↗Enrolled (actual)
27
Serious AEs
0.0%
Results posted
Oct 2024
Primary outcome: Primary: Sarcoplasmic Reticulum Composition — 2.0; 2.2 PC:PE ratio
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- muscle biopsy (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Washington University School of Medicine
- Primary completion
- Feb 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Sarcoplasmic Reticulum Composition |
2.0; 2.2 | — |
| SECONDARY Insulin Sensitivity |
2.5; 5.6 | — |
| SECONDARY Lean and Fat Body Mass |
43.7; 30.6 | — |
Summary
The investigators previous research has suggested that lipid (fatty) composition in the muscle cells of mice plays a key role in their insulin sensitivity. The purpose of this study is to determine whether these specific fat signatures translate to humans by comparing the muscle of healthy patients to those with pre-diabetes, or "the metabolic syndrome".
Eligibility Criteria
Control subjects
Inclusion:
Sedentary: No routine exercise, walking 18 and 18 and 30
Meet at least three of the following Adult Treatment Panel (ATP) III criteria for the metabolic syndrome:
waist circumference > or = 40 inches in men, > or = 35 inches in women blood triglycerides > or = 150 mg/dL blood HDL cholesterol or = 130 mmHg systolic, or > or = 85 mmHg diastolic fasting blood sugar > or = 100 mg/dL
Exclusion:
Diagnosed with Type 2 diabetes, coronary artery disease, cancer, liver, lung, or kidney disease or any other major illness
Currently on any significant prescription medications other than:
oral contraceptives in women More than two standard medication for stage 1 hypertension in men or women (blood pressure 140-159/90-99) Currently Pregnant Current Tobacco Use
Data sourced from ClinicalTrials.gov (NCT02122666). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.