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

Diabetes Mellitus, Type 1 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00592072
• Other study ID #: DK66108b_0505000079
• Secondary ID: R37DK020495DK204
• Status: Completed
• Phase: N/A
• First received: December 26, 2007
• Last updated: January 8, 2015
• Start date: July 2005
• Est. completion date: July 2008

Study information

• Verified date: January 2015
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.)

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: July 2008
• Est. primary completion date: July 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Hypoglycemia

Intervention

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:
• Splenda (Placebo Control)
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.

Locations

Country	Name	City	State
United States	Yale University School of Medicine	New Haven	Connecticut

Sponsors (3)

Lead Sponsor	Collaborator
Yale University	Juvenile Diabetes Research Foundation, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	90 minutes	No
Primary	Delayed Verbal Memory	The highest score is 25 and the lowest score is 0. The higher scored indicate an improvement.	90 minutes	No
Primary	Verbal Memory Recognition	The highest score is 15. The lowest score is 0. Higher scores indicate an improvement.	90 minutes	No
Primary	Digit Span Backward	The highest score is 35. The lowest score is 0. The higher the score indicates an improvement.	90 minutes	No
Primary	Letter/Number Sequencing	The highest score is 21. The lowest score is 0. Higher scores indicate an improvement.	90 minutes	No
Primary	Digit Symbol Coding	The highest score is 133. The lowest score is 0. Higher scores indicate an improvement.	90 minutes	No
Primary	Map Search (2min)	The highest score is 80. The lowest score is 0. Higher scores indicate an improvement.	90 minutes	No
Primary	Map Search (1min)	The highest score is 80. The lowest score is 0. Higher scores indicate an improvement.	90 minutes	No
Primary	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.	90 minutes	No