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N/A N=23 Basic Science

Insulin Resistance in Adolescents

Insulin Resistance

Bottom Line

View on ClinicalTrials.gov: NCT04089332 ↗
Enrolled (actual)
23
Serious AEs
0.0%
Results posted
Sep 2024
Primary outcome: Primary: Linear Relationship Between HOMA-IR and Cognitive Function (R-squared) — 0.205; 0.299; 0.738; 0.0264 R-squared — p=0.162

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Oral Glucose Tolerance Test (OGTT) (Other); 3 Tesla MRI (Device); Intravenous Catheter (Device); Cognitive Tests (Other)
Age
Pediatric, Adult · 12+ yrs
Sex
All
Sponsor
University of Wisconsin, Madison
Primary completion
Jul 2022

Outcome Measures

OutcomeResultp-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 —

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.

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
View full record on ClinicalTrials.gov →

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.

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