N/A
N=12
Effect of Medium Chain Fatty Acids on Cognitive Function During Acute Hypoglycemia in Patients With Type 1 Diabetes
Diabetes Mellitus, Type 1
Bottom Line
View on ClinicalTrials.gov: NCT00592072 ↗Enrolled (actual)
12
Serious AEs
0.0%
Results posted
Jan 2015
Primary outcome: Primary: Immediate Verbal Memory — 15.85; 17.36; 14.97; 13.28 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Medium chain fatty acid (Octanoic and Decanoic acid) (Dietary_supplement); Splenda (Placebo Control) (Other)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Yale University
- Primary completion
- Jul 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Immediate Verbal Memory |
15.85; 17.36; 14.97; 13.28 | — |
| PRIMARY Delayed Verbal Memory |
14.82; 15.33; 14.80; 11.58 | — |
| PRIMARY Verbal Memory Recognition |
13.19; 14.27; 13.29; 12.14 | — |
| PRIMARY Digit Span Backward |
0.60; 0.64; 0.58; 0.54 | — |
| PRIMARY Letter/Number Sequencing |
12.04; 11.07; 10.97; 9.92 | — |
| PRIMARY Digit Symbol Coding |
72.50; 74.04; 74.99; 68.56 | — |
| PRIMARY Map Search (2min) |
73.30; 75.04; 75.11; 74.67 | — |
| PRIMARY Map Search (1min) |
53.11; 50.35; 48.42; 42.94 | — |
| PRIMARY Telephone Search |
2.86; 3.14; 3.06; 3.46 | — |
Summary
At present, there are no therapeutic agents that can minimize severe hypoglycemia (low blood sugar) and its effects on long-term brain function. The aim of this study is to determine whether the human brain is able to use medium chain fatty acids (MCFA) and/or their metabolites as an alternative fuel source during acute hypoglycemia in patients with Type 1 Diabetes Mellitus (T1DM). The hypothesis is that medium chain fatty acids will provide a rapidly absorbed, non-carbohydrate fuel that will improve cognitive performance during episodes of hypoglycemia (low blood sugar.)
Eligibility Criteria
Inclusion Criteria
- Type 1 Diabetes Mellitus for greater than 5 years (C-peptide negative)
- Age 18-55 years
- Subject is on intensive insulin therapy resulting in a Hemoglobin A1c of less than 7.5%
- History of frequent hypoglycemic events as defined as having at least one blood glucose of less than 60 mg/dl in the last four weeks
Exclusion Criteria
- History of hypoglycemia induced seizures
- Pregnancy
- Significant baseline anemia (hemoglobin < 11.0g/dl or hematocrit < 33%)
- A history of liver cirrhosis or porto-caval shunt surgery
Data sourced from ClinicalTrials.gov (NCT00592072). 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.