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

Early Phase 1CompletedNCT03469492

Yale University8 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Hyperglycaemia (Diabetic)

Interventions

InsulinDRUG

Insulin regimens will be adjusted on a weekly basis as needed to achieve a target blood glucose level.

exerciseBEHAVIORAL

Exercise in accordance to the guidelines established by the American Diabetes Association.

Dietary counselingDIETARY_SUPPLEMENT

Dietary counseling in accordance to the guidelines established by the American Diabetes Association.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 Years

Medical Language ↔ Plain English

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 \< 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

Locations (1)

The Anylan Center

New Haven, Connecticut, United States

Outcomes

Primary Outcomes

Change in HbA1c Levels

HbA1c levels measured by MRS scanning during a hyperglycaemic clamp. Result reported is the mean decrease in HbA1C. A decrease in HbA1c indicates improvement in brain glucose levels.

Time frame: Baseline and 12 weeks

Secondary Outcomes

Gluthathione

baseline MRS scan to measure gluthathione

Time frame: 0 weeks

Gluthathione

MRS scan to measure gluthathione

Time frame: 12 weeks

Plasma Glucose

MRS scan to measure plasma glucose

Time frame: 0 weeks

Plasma Glucose

MRS scan to measure plasma glucose

Time frame: 12 weeks

Plasma Fructose

MRS scan to measure plasma fructose

Time frame: 0 weeks

Plasma Fructose

MRS scan to measure plasma fructose

Time frame: 12 weeks

Plasma Insulin

MRS scan to measure plasma insulin

Time frame: 0 weeks

Plasma Insulin

MRS scan to measure plasma insulin

Time frame: 12 weeks

Data from ClinicalTrials.gov

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