N/A N=6

Testing Glial Pathways to HAAF in Human Subjects Using Carbon 13 Magnetic Resonance Spectroscopy

Diabetes Complications · Hypoglycemia

Bottom Line

View on ClinicalTrials.gov: NCT02690168 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jul 2021

Primary outcome: Primary: Percent Enrichment of Bicarbonate as Measured by Magnetic Resonance Spectroscopy (MRS) — 61.9 % enrichment — p=0.0053

Study Design & Population

Study type: Observational
Phase: N/A
Interventions: Fasting (Behavioral)
Age: Adult · 18+ yrs
Sex: Male
Sponsor: Pennington Biomedical Research Center
Primary completion: Mar 2017

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

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.

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

View full record on ClinicalTrials.gov →

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.