Early Phase 1
Completed N=8
Investigating the Role of the Polyol Pathway in the Central Nervous System Production of Fructose
Hyperglycaemia (Diabetic)
Source: ClinicalTrials.gov NCT03469492 ↗
Enrolled (actual)
8
Serious AEs
0.0%
Results posted
Feb 2023
Primary outcomePrimary: Change in HbA1c Levels — 24.3 mmol/mol — p=0.006
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in HbA1c Levels |
24.3 | 0.006 sig |
| SECONDARY Gluthathione |
— | — |
| SECONDARY Plasma Glucose |
0.88 | 0.266 |
| SECONDARY Plasma Fructose |
— | — |
| SECONDARY Plasma Insulin |
38 | 0.25 |
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
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. Informational only — not medical advice.