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

Not Applicable

Completed

• Conditions: Hyperglycemia
• Interventions: Other: Brain MRS during hyperglycemic clamp; Other: Analysis of Metabolites in cerebrospinal fluid

• Registration Number: NCT02272556
• Lead Sponsor: Yale University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-10-20
• Study First Submitted QC: 2014-10-20
• Study First Posted: 2014-10-23
• Study Start: 2015-02
• Primary Completion: 2022-05-18
• Study Completion: 2022-05-18
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-15
• Last Update Posted: 2022-08-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 138

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Non-Diabetic Obese	Brain MRS during hyperglycemic clamp	Age-matched, non-diabetic obese (BMI \> 30 kg/m\^3) individuals
Non-Diabetic Obese	Analysis of Metabolites in cerebrospinal fluid	Age-matched, non-diabetic obese (BMI \> 30 kg/m\^3) individuals
Subjects with Type 2 Diabetes	Brain MRS during hyperglycemic clamp	Type 2 DM subjects with HbA1C \> 7.5% treated with metformin, sulfonylurea, insulin or combination
Subjects with Type 2 Diabetes	Analysis of Metabolites in cerebrospinal fluid	Type 2 DM subjects with HbA1C \> 7.5% treated with metformin, sulfonylurea, insulin or combination
Lean, healthy control subjects	Analysis of Metabolites in cerebrospinal fluid	Age-matched, lean, healthy control subjects (BMI \< 25 kkg/m\^3)
Lean, healthy control subjects	Brain MRS during hyperglycemic clamp	Age-matched, lean, healthy control subjects (BMI \< 25 kkg/m\^3)

Primary Outcome Measures

Name	Time	Method
Metabolite Measurements by MRS	4 hours post hyperglycemia	metabolite levels will be measured by MRS

Secondary Outcome Measures

Name	Time	Method
Satiety Ratings	4 hours post hyperglycemia	Satiety will be measured using a visual analog scale
Hunger Ratings	4 hours post hyperglycemia	Hunger will be measured using a visual analog scale
Cognitive State	4 hours post hyperglycemia	Participants will be asked to complete basic cognitive testing using the mini-mental status exam and the Montreal cognitive assessment

Trial Locations

Locations (1)

Yale University; 🇺🇸 New Haven, Connecticut, United States