N/A
Completed N=41
Fatty Acid Oxidation Defects and Insulin Sensitivity
Very Long-chain Acyl-CoA Dehydrogenase Deficiency · Trifunctional Protein Deficiency · Long-chain 3-hydroxyacyl-CoA Dehydrogenase Deficiency · Medium-chain Acyl-CoA Dehydrogenase Deficiency
Source: ClinicalTrials.gov NCT02517307 ↗
Enrolled (actual)
41
Serious AEs
5.1%
Results posted
Jan 2024
Primary outcomePrimary: Glucose Disposal Rate (Rd)- the Rate of Glucose Infusion to Maintain Euglycemia During Steady State Insulin Infusion in mg/Min — 709; 429; 842; 497 mg/min — p=0.136
Summary
The purpose of this study is to learn more about what causes insulin resistance. It has been suggested that proper breakdown of fat into energy (oxidation) in the body is important to allow insulin to keep blood sugar in the normal range. The investigators want to know if having one of the fatty acid oxidation disorders could have an influence on insulin action. Fatty acid oxidation disorders are genetic disorders that inhibit one of the enzymes that converts fat into energy. The investigators will study both normal healthy people and people with a long-chain fatty acid oxidation disorder.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Glucose Disposal Rate (Rd)- the Rate of Glucose Infusion to Maintain Euglycemia During Steady State Insulin Infusion in mg/Min |
709; 429; 842; 497 | 0.136 |
| SECONDARY Endogenous Glucose Production (Ra) - Calculated by the Equations of Steele During Steady State in mg/Min |
84.7; 97.2; 50.2; 106 | 0.011 sig |
Eligibility Criteria
Inclusion Criteria
- confirmed diagnosis of VLCAD, LCHAD, TFP or MCAD deficiency or same gender, age and BMI as a subject with a fatty acid oxidation disorder
- ability to travel to Oregon Health & Science University, Portland, Oregon
- ability and willingness to complete the protocol
Exclusion Criteria
- hemoglobin 1.2 Prothrombin time (PTT) >36 sec, Platelets <150K/mm3
- pregnant or lactating females
- endocrine disorder such as diabetes or untreated thyroid disease
- cardiovascular disease or elevated plasma lipids
- regularly taking meds that strongly affect bleeding, bruising or platelets
Data sourced from ClinicalTrials.gov (NCT02517307). 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.