Investigating the Role of the Polyol Pathway in the Central Nervous System Production of Fructose

• Status: Active, not recruiting
• Trial end date: 2021-12-01
• Target enrollment: 0
• Participant gender: All

Summary

To investigate whether longer-term improvement of glycemic control in poorly controlled diabetes patients with a 12-week intensified insulin treatment regimen will lead to decreased polyol pathway activity.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Yale University
• Treatments: Insulin; Insulin, Globin Zinc

Criteria

Inclusion Criteria:

• 15 Type 2 DM subjects with HbA1C > 7.5%

• 15 Type 1 DM subjects with HbA1C > 7.5%

• Age 18-60

• BMI ≥18 kg/m2

• Weight ≤ 285 pounds

Exclusion Criteria:

• Creatinine > 1.5 mg/dL, Hgb < 10 mg/dL, ALT > 2.5 X ULN,

• untreated thyroid disease,

• uncontrolled hypertension,

• known neurological disorders,

• untreated psychiatric disorders,

• malignancy,

• bleeding disorders,

• current or recent steroid use in last 3 months,

• illicit drug use;

• for women: pregnancy, actively seeking pregnancy, or breastfeeding; inability to enter

• MRI/MRS