NCT03469492

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

Investigating the Role of the Polyol Pathway in the Central Nervous System Production of Fructose: an Intervention Study

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: Yale University · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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.

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 higher intracellular glutathione levels. Furthermore, following longer-term improved glycemic control, patients may also have down-regulation of the pathway as reflected by decreased production of intracellular fructose in response to hyperglycemic clamp.

Conditions

• Hyperglycaemia (Diabetic)

Interventions

Type	Name	Description
DRUG	Insulin	Insulin regimens will be adjusted on a weekly basis as needed to achieve a target blood glucose level.
BEHAVIORAL	exercise	Exercise in accordance to the guidelines established by the American Diabetes Association.
DIETARY_SUPPLEMENT	Dietary counseling	Dietary counseling in accordance to the guidelines established by the American Diabetes Association.

Timeline

• Start date: 2018-01-18
• Primary completion: 2020-03-20
• Completion: 2020-03-20
• First posted: 2018-03-19
• Last updated: 2024-02-05
• Results posted: 2023-02-02

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study