N/A
Completed N=6
Testing Glial Pathways to HAAF in Human Subjects Using Carbon 13 Magnetic Resonance Spectroscopy
Diabetes Complications · Hypoglycemia
Source: ClinicalTrials.gov NCT02690168 ↗
Enrolled (actual)
6
Serious AEs
0.0%
Results posted
Jul 2021
Primary outcomePrimary: Percent Enrichment of Bicarbonate as Measured by Magnetic Resonance Spectroscopy (MRS) — 61.9 % enrichment — p=0.0053
Summary
Hypoglycemia-associated autonomic failure (HAAF), a condition commonly developed in diabetic patients, which causes them to have severely low blood sugar levels. This condition makes clinical management of blood sugar in diabetic patients very challenging. This research seeks to better understand how diabetic patients develop HAAF, and what can be done to prevent it.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Enrichment of Bicarbonate as Measured by Magnetic Resonance Spectroscopy (MRS) |
61.9 | 0.0053 sig |
| SECONDARY Cerebral Metabolic Rate of Acetate Ascertained Through Mathematical Modeling of MRS Data |
71 | 0.477 |
| SECONDARY Astroglial TCA Cycle Rate Ascertained Through Mathematical Modeling of MRS Data |
0.4 | 0.917 |
| SECONDARY Glucose Level |
71 | — |
| SECONDARY Change in Leptin Levels |
5.2 | 0.53 |
Eligibility Criteria
Inclusion Criteria
- Male
- BMI 20.0-24.9 kg/m2
- 18-40 years old
- Willing to reside at Pennington Biomedical for 4 days
Exclusion Criteria
- Type 1 diabetes mellitus
- Type 2 diabetes mellitus
- Fasting glucose ≥ 110 mg/dL (determined at screening visit)
- Hyperketonuria >15 mg/dL, (determined at screening visit)
- Contraindication to MRI
- History of or current eating disorder
- History of obsessive compulsive disorder
- Current use of any medication (excluding over-the-counter pain medication)
- Contraindication to prolonged fasting
- Consume >10 alcoholic drinks/week
Data sourced from ClinicalTrials.gov (NCT02690168). 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.