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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

138 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-02-28

Study Completion Date

2022-05-18

Brief Summary

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Patients will undergo magnetic resonance spectroscopy (MRS) scanning to noninvasively measure intracerebral and plasma metabolite levels at baseline and following 2 and 4 hours of hyperglycemia. Subjects will also undergo a lumbar puncture at a separate occasion to assess cerebrospinal fluid levels of metabolites.

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Detailed Description

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Conditions

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Hyperglycemia

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Subjects with Type 2 Diabetes

Type 2 DM subjects with HbA1C \> 7.5% treated with metformin, sulfonylurea, insulin or combination

Group Type ACTIVE_COMPARATOR

Brain MRS during hyperglycemic clamp

Intervention Type OTHER

All patients will undergo brain MRS at baseline and following 2 and 4 hours of hyperglycemia using the clamp technique

Analysis of Metabolites in cerebrospinal fluid

Intervention Type OTHER

All patients will have the option to undergo a lumbar puncture for analysis of metabolites in cerebrospinal fluid

Non-Diabetic Obese

Age-matched, non-diabetic obese (BMI \> 30 kg/m\^3) individuals

Group Type ACTIVE_COMPARATOR

Brain MRS during hyperglycemic clamp

Intervention Type OTHER

All patients will undergo brain MRS at baseline and following 2 and 4 hours of hyperglycemia using the clamp technique

Analysis of Metabolites in cerebrospinal fluid

Intervention Type OTHER

All patients will have the option to undergo a lumbar puncture for analysis of metabolites in cerebrospinal fluid

Lean, healthy control subjects

Age-matched, lean, healthy control subjects (BMI \< 25 kkg/m\^3)

Group Type ACTIVE_COMPARATOR

Brain MRS during hyperglycemic clamp

Intervention Type OTHER

All patients will undergo brain MRS at baseline and following 2 and 4 hours of hyperglycemia using the clamp technique

Analysis of Metabolites in cerebrospinal fluid

Intervention Type OTHER

All patients will have the option to undergo a lumbar puncture for analysis of metabolites in cerebrospinal fluid

Interventions

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Brain MRS during hyperglycemic clamp

All patients will undergo brain MRS at baseline and following 2 and 4 hours of hyperglycemia using the clamp technique

Intervention Type OTHER

Analysis of Metabolites in cerebrospinal fluid

All patients will have the option to undergo a lumbar puncture for analysis of metabolites in cerebrospinal fluid

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Type 2 DM with HbA1C treated with metformin, sulfonylurea, insulin, or combination OR age-matched, non-diabetic obese (BMI \> 30 kg/m\^2) OR age-matched lean, healthy control subjects (BMI \< 25 kg/m\^2)
* Age 18-55
* BMI 18-45 kg/m\^2

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
* Smoking
* Current or recent steroid use in last 3 months
* Illicit drug use
* Pregnancy, actively seeking pregnancy, or breastfeeding
* Inability to enter MRI/MRS

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes