Early Phase 1 N=8 Treatment

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

Hyperglycaemia (Diabetic)

Bottom Line

View on ClinicalTrials.gov: NCT03469492 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Feb 2023

Primary outcome: Primary: Change in HbA1c Levels — 24.3 mmol/mol — p=0.006

Study Design & Population

Study type: Interventional
Phase: Early Phase 1
Interventions: Insulin (Drug); exercise (Behavioral); Dietary counseling (Dietary_supplement)
Age: Adult · 18+ yrs
Sex: All
Sponsor: Yale University
Primary completion: Mar 2020

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in HbA1c Levels	24.3	0.006 sig
SECONDARY Gluthathione	—	—
SECONDARY Gluthathione	—	—
SECONDARY Plasma Glucose	0.88	0.266
SECONDARY Plasma Glucose	0.88	0.266
SECONDARY Plasma Fructose	—	—
SECONDARY Plasma Fructose	—	—
SECONDARY Plasma Insulin	38	0.25
SECONDARY Plasma Insulin	38	0.25

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.

Eligibility 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 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03469492). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.