Investigating the Role of the Polyol Pathway in the Central Nervous System
Investigating the Role of Polyol Pathway in the Central Nervous System
1 other identifier
interventional
138
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Feb 2015
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 20, 2014
CompletedFirst Posted
Study publicly available on registry
October 23, 2014
CompletedStudy Start
First participant enrolled
February 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 18, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
May 18, 2022
CompletedAugust 18, 2022
August 1, 2022
7.3 years
October 20, 2014
August 15, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Metabolite Measurements by MRS
metabolite levels will be measured by MRS
4 hours post hyperglycemia
Secondary Outcomes (3)
Hunger Ratings
4 hours post hyperglycemia
Satiety Ratings
4 hours post hyperglycemia
Cognitive State
4 hours post hyperglycemia
Other Outcomes (2)
Cerebrospinal fluid cell count
2 weeks post MRS testing
protein levels
2 weeks post MRS testing
Study Arms (3)
Subjects with Type 2 Diabetes
ACTIVE COMPARATORType 2 DM subjects with HbA1C \> 7.5% treated with metformin, sulfonylurea, insulin or combination
Non-Diabetic Obese
ACTIVE COMPARATORAge-matched, non-diabetic obese (BMI \> 30 kg/m\^3) individuals
Lean, healthy control subjects
ACTIVE COMPARATORAge-matched, lean, healthy control subjects (BMI \< 25 kkg/m\^3)
Interventions
All patients will undergo brain MRS at baseline and following 2 and 4 hours of hyperglycemia using the clamp technique
All patients will have the option to undergo a lumbar puncture for analysis of metabolites in cerebrospinal fluid
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Yale Universitylead
- American Diabetes Associationcollaborator
Study Sites (1)
Yale University
New Haven, Connecticut, 06519, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Robert Sherwin, MD
Yale University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 20, 2014
First Posted
October 23, 2014
Study Start
February 1, 2015
Primary Completion
May 18, 2022
Study Completion
May 18, 2022
Last Updated
August 18, 2022
Record last verified: 2022-08