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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-18

Study Completion Date

2020-03-20

Brief Summary

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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.

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Detailed Description

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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

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Hyperglycaemia (Diabetic)

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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type 2 diabetes mellitus

Subjects with type 2 diabetes on insulin.

Group Type ACTIVE_COMPARATOR

Insulin

Intervention Type DRUG

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

exercise

Intervention Type BEHAVIORAL

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

Dietary counseling

Intervention Type DIETARY_SUPPLEMENT

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

type 1 diabetes mellitus

Subjects with type 1 diabetes on insulin.

Group Type ACTIVE_COMPARATOR

Insulin

Intervention Type DRUG

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

exercise

Intervention Type BEHAVIORAL

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

Dietary counseling

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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Insulin

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

Intervention Type DRUG

exercise

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

Intervention Type BEHAVIORAL

Dietary counseling

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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No