Status:
COMPLETED
Investigating the Role of the Polyol Pathway in the Central Nervous System Production of Fructose
Lead Sponsor:
Yale University
Collaborating Sponsors:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
Hyperglycaemia (Diabetic)
Eligibility:
All Genders
18-60 years
Phase:
EARLY_PHASE1
Brief 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 act...
Detailed Description
Polyol pathway activity will decrease in diabetic individuals who undergo intensification of their insulin treatment regimens as reflected by lower baseline brain intracellular fructose levels and hig...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 18 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 20 2020
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT03469492
Start Date
January 18 2018
End Date
March 20 2020
Last Update
February 5 2024
Active Locations (1)
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1
The Anylan Center
New Haven, Connecticut, United States, 06511