N/A
Completed N=23
Insulin Resistance in Adolescents
Source: ClinicalTrials.gov NCT04089332 ↗Enrolled (actual)
23
Serious AEs
0.0%
Results posted
Sep 2024
Primary outcomePrimary: Linear Relationship Between HOMA-IR and Cognitive Function (R-squared) — 0.205; 0.299; 0.738; 0.0264 R-squared — p=0.162
Summary
The growing population of adolescents with insulin resistance (IR) is predicted to create a large public health burden in the next few decades. This study examines the function of brain blood vessels and cognitive function, to test if increasing severity of IR in adolescents is related to reduced cognitive function and reduced brain blood vessel function. Findings from this study may help create treatments to delay or prevent some of the negative effects of IR on cognitive and vascular health.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Linear Relationship Between HOMA-IR and Cognitive Function (R-squared) |
0.205; 0.299; 0.738; 0.0264; 0.186; 0.04 | 0.162 |
| PRIMARY Change in Cerebral Blood Flow (CBF) as Determined by MRI (mL/100g/Min) |
64.25666; 66.96387836; 2.707215114 | 0.558 |
| PRIMARY Linear Relationship Between Cerebral Blood Flow and Cognitive Function (R-squared) |
0.132; 0.119; 0.06; 0.0593; 0.366; 0.000497 | 0.377 |
| PRIMARY Mediation Analysis of the Indirect Effect of Cerebral Blood Flow on Insulin Resistance and Cognitive Function |
1.6787; -3.3431; -0.8194; -0.1702; -0.2095; 30.7925 | — |
Eligibility Criteria
Inclusion Criteria
- Age 12-18 years inclusive
- Typically developing and cognitively intact
Exclusion Criteria
- Diabetes (≥126 mg dL-1 fasting glucose)
- Insulin treatment or sensitizing drugs
- Diagnosis of kidney, pulmonary, or heart disease
- Current smoking (defined as use of nicotine >5 times in the past month)
- Pregnancy
- Neurological or developmental disorders (e.g., intellectual disability, autism)
- Significant head injury or medical conditions (e.g., concussion, encephalopathy, seizure disorder)
- Inability to undergo the MRI procedure
- Weight less than 94.5 lbs (42.9 kg) to adhere to safety guidelines regarding blood sampling and OGTT administration
- Tanner Stage <3
- Any other circumstance deemed by the PI not addressed above
Data sourced from ClinicalTrials.gov (NCT04089332). 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. Informational only — not medical advice.