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

NCT03469492 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2024-02-05

Study results available
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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.

Conditions

  • Hyperglycaemia (Diabetic)

Interventions

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.

Sponsors & Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

    collaborator NIH

  • Yale University

    lead OTHER

Principal Investigators

  • Janice Hwang, MD · Section of Endocrinology

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-01-18
Primary Completion
2020-03-20
Completion
2020-03-20
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03469492 on ClinicalTrials.gov