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Effect of Medium Chain Fatty Acids on Cognitive Function During Acute Hypoglycemia in Patients With Type 1 Diabetes

This study has been completed.
Sponsor:
Collaborators:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Juvenile Diabetes Research Foundation
Information provided by:
Yale University
ClinicalTrials.gov Identifier:
NCT00592072
First received: December 26, 2007
Last updated: March 14, 2011
Last verified: March 2011
History of Changes
  Purpose

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.)


Condition Intervention
Diabetes Mellitus, Type 1
 Dietary Supplement: Medium chain fatty acid (Octanoic and Decanoic acid)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Medium Chain Fatty Acids on Cognitive Function During Acute Hypoglycemia in Patients With Type 1 Diabetes

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Yale University:

Primary Outcome Measures:
  • Cognitive performance [ Time Frame: 90 minutes ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Blood glucose [ Time Frame: 5 minutes ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 12
Study Start Date: July 2005
Study Completion Date: July 2008
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Dietary Supplement: Medium chain fatty acid (Octanoic and Decanoic acid)
    Octanoic acid(67%) and Decanoic acid (27%); MCFA 50g total at 25 minute intervals with front loading of 20g then 10g for three administrations.
    Other Names:
    • Medium Chain Triglycerides
    • Octanoic and Decanoic acid
    • Fractionated coconut oil
Detailed Description:

Twelve subjects between the ages of 18 years and 55 years who have had Type 1 Diabetes Mellitus for more than five years and have had tight control of their diabetes as determined by screening blood work will be invited to participate. Each study subject will undergo two hypoglycemic clamp studies (a procedure where the blood sugar is closely regulated with intravenous insulin and glucose.) In these hypoglycemic clamp studies, cognitive testing will be performed during 90 minutes of normal blood glucose followed by 90 minutes of hypoglycemia. During the hypoglycemic period, either the MCFA or a placebo will be administered. Each subject will experience both conditions. The order in which the MCFA is given will be randomized.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00592072

Locations
United States, Connecticut
Yale University School of Medicine
New Haven, Connecticut, United States, 06520
Sponsors and Collaborators
Yale University
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Juvenile Diabetes Research Foundation
Investigators
Principal Investigator: Robert Sherwin, M.D. Yale University
  More Information

No publications provided

Responsible Party: Robert Sherwin, M.D., Yale University School of Medicine
ClinicalTrials.gov Identifier: NCT00592072     History of Changes
Other Study ID Numbers: DK66108b_0505000079, R37DK020495, DK20495
Study First Received: December 26, 2007
Last Updated: March 14, 2011
Health Authority: United States: Federal Government

Keywords provided by Yale University:
Diabetes Mellitus, Type 1
Medium Chain Fatty Acid
Hypoglycemia

Additional relevant MeSH terms:
Diabetes Mellitus, Type 1
Diabetes Mellitus
Hypoglycemia
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
 Immune System Diseases
Decanoic acid
Antifungal Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 17, 2013