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

Yale University

Status: Completed

Conditions: Hyperglycemia

Treatments: Other: Brain MRS during hyperglycemic clamp; Other: Analysis of Metabolites in cerebrospinal fluid

Study type: Interventional

Funder types: Other

Identifiers

NCT02272556

1408014461

Details and patient eligibility

About

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.

Enrollment: 138 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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138 participants in 3 patient groups

Subjects with Type 2 Diabetes

Active Comparator group

Description:

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

Treatment:

Other: Brain MRS during hyperglycemic clamp

Other: Analysis of Metabolites in cerebrospinal fluid

Non-Diabetic Obese

Active Comparator group

Description:

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

Treatment:

Other: Brain MRS during hyperglycemic clamp

Other: Analysis of Metabolites in cerebrospinal fluid

Lean, healthy control subjects

Active Comparator group

Description:

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

Treatment:

Other: Brain MRS during hyperglycemic clamp

Other: Analysis of Metabolites in cerebrospinal fluid