search
Back to results

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

Primary Purpose

Diabetes Mellitus, Type 1

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Medium chain fatty acid (Octanoic and Decanoic acid)
Splenda (Placebo Control)
Sponsored by
Yale University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 1 focused on measuring Diabetes Mellitus, Type 1, Medium Chain Fatty Acid, Hypoglycemia

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Yale University School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Medium chain fatty acid (Octanoic and Decanoic acid)

Splenda (Placebo Control)

Arm Description

Outcomes

Primary Outcome Measures

Immediate Verbal Memory
Results of cognitive function in diabetic patients using tests such as digit symbol substitution (a test of memory), tests of everyday attention, telephone book searching and map searching during either administration of medium chain triglyceride oil or a control solution. The goal was to determine whether the human brain is able to use medium-chain fatty acids (MCFA) and /or their metabolites as an alternative fuel source and thus improve brain function during acute hypoglycemia in patients with type 1 diabetes. The lowest score is 0 and the highest score is 25. A higher score is an improvement.
Delayed Verbal Memory
The highest score is 25 and the lowest score is 0. The higher scored indicate an improvement.
Verbal Memory Recognition
The highest score is 15. The lowest score is 0. Higher scores indicate an improvement.
Digit Span Backward
The highest score is 35. The lowest score is 0. The higher the score indicates an improvement.
Letter/Number Sequencing
The highest score is 21. The lowest score is 0. Higher scores indicate an improvement.
Digit Symbol Coding
The highest score is 133. The lowest score is 0. Higher scores indicate an improvement.
Map Search (2min)
The highest score is 80. The lowest score is 0. Higher scores indicate an improvement.
Map Search (1min)
The highest score is 80. The lowest score is 0. Higher scores indicate an improvement.
Telephone Search
This is a ratio of how many symbols are found during a certain period of time. The highest ratio is the best result.

Secondary Outcome Measures

Full Information

First Posted
December 26, 2007
Last Updated
January 8, 2015
Sponsor
Yale University
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Juvenile Diabetes Research Foundation
search

1. Study Identification

Unique Protocol Identification Number
NCT00592072
Brief Title
Effect of Medium Chain Fatty Acids on Cognitive Function During Acute Hypoglycemia in Patients With Type 1 Diabetes
Official Title
Effect of Medium Chain Fatty Acids on Cognitive Function During Acute Hypoglycemia in Patients With Type 1 Diabetes
Study Type
Interventional

2. Study Status

Record Verification Date
January 2015
Overall Recruitment Status
Completed
Study Start Date
July 2005 (undefined)
Primary Completion Date
July 2008 (Actual)
Study Completion Date
July 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yale University
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Juvenile Diabetes Research Foundation

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.)
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 1
Keywords
Diabetes Mellitus, Type 1, Medium Chain Fatty Acid, Hypoglycemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Medium chain fatty acid (Octanoic and Decanoic acid)
Arm Type
Experimental
Arm Title
Splenda (Placebo Control)
Arm Type
Placebo Comparator
Intervention Type
Dietary Supplement
Intervention Name(s)
Medium chain fatty acid (Octanoic and Decanoic acid)
Other Intervention Name(s)
Medium Chain Triglycerides, Octanoic and Decanoic acid, Fractionated coconut oil
Intervention Description
Octanoic acid(67%) and Decanoic acid (27%); MCFA 50g total at 25 minute intervals with front loading of 20g then 10g for three administrations.
Intervention Type
Other
Intervention Name(s)
Splenda (Placebo Control)
Intervention Description
Placebo drink will consist of dietary sweetener Splenda mixed in water at a concentration of 1g/100mL. An unsweetened cherry flavor Koolaid mix will be added at a concentration of 0.3g/100mL of the Splenda drink to enhance flavor.
Primary Outcome Measure Information:
Title
Immediate Verbal Memory
Description
Results of cognitive function in diabetic patients using tests such as digit symbol substitution (a test of memory), tests of everyday attention, telephone book searching and map searching during either administration of medium chain triglyceride oil or a control solution. The goal was to determine whether the human brain is able to use medium-chain fatty acids (MCFA) and /or their metabolites as an alternative fuel source and thus improve brain function during acute hypoglycemia in patients with type 1 diabetes. The lowest score is 0 and the highest score is 25. A higher score is an improvement.
Time Frame
90 minutes
Title
Delayed Verbal Memory
Description
The highest score is 25 and the lowest score is 0. The higher scored indicate an improvement.
Time Frame
90 minutes
Title
Verbal Memory Recognition
Description
The highest score is 15. The lowest score is 0. Higher scores indicate an improvement.
Time Frame
90 minutes
Title
Digit Span Backward
Description
The highest score is 35. The lowest score is 0. The higher the score indicates an improvement.
Time Frame
90 minutes
Title
Letter/Number Sequencing
Description
The highest score is 21. The lowest score is 0. Higher scores indicate an improvement.
Time Frame
90 minutes
Title
Digit Symbol Coding
Description
The highest score is 133. The lowest score is 0. Higher scores indicate an improvement.
Time Frame
90 minutes
Title
Map Search (2min)
Description
The highest score is 80. The lowest score is 0. Higher scores indicate an improvement.
Time Frame
90 minutes
Title
Map Search (1min)
Description
The highest score is 80. The lowest score is 0. Higher scores indicate an improvement.
Time Frame
90 minutes
Title
Telephone Search
Description
This is a ratio of how many symbols are found during a certain period of time. The highest ratio is the best result.
Time Frame
90 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Sherwin, M.D.
Organizational Affiliation
Yale University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yale University School of Medicine
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06520
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs