Blood/Interstitial Glucose Measurements and Cognitive Function During Hypoglycemia and Recovery

Joslin Diabetes Center

Status: Completed

Conditions: Hypoglycemia

Treatments: Procedure: euglycemic and hypoglycemic clamp

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01283126

CHS #: 2010-09

Details and patient eligibility

About

The purpose of this study is to find out the effects of hypoglycemia on cognition in healthy individuals and how well changes in (interstitial) tissue glucose levels correlate with changes in cognitive function as compared to blood glucose levels.

Full description

Subjects will undergo hypoglycemic clamps during which interstitial glucose will be measured and cognitive function will be assessed.

Enrollment: 20 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• non obese (BMI <30), ages 18-50

Exclusion criteria

• renal or hepatic failure

• cancer or lymphoma

• malabsorption or malnourishment

• hypercortisolism

• alcoholism or drug abuse

• anemia

• eating disorder or depression

• coronary artery disease

• Arrhythmias

• hypertension

• on medications known to affect the blood glucose to be measured such as

• glucocorticoids

• on blood thinning agents

  • Pregnant women, breastfeeding women and women who want to become pregnant in the next 6 months will be excluded from the study.
  • Subjects who have donated blood two weeks prior to the study.
  • Allergies to pig derived products (Heparin will be used)

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Euglycemic and hypoglycemic clamp

Experimental group

Description:

Subjects will complete clamp study visit.

Treatment:

Procedure: euglycemic and hypoglycemic clamp