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

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ClinicalTrials.gov Identifier: NCT02272556
Recruitment Status : Recruiting
First Posted : October 23, 2014
Last Update Posted : January 14, 2019
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Hyperglycemia Other: Brain MRS during hyperglycemic clamp Other: Analysis of Metabolites in cerebrospinal fluid Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 45 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Investigating the Role of Polyol Pathway in the Central Nervous System
Study Start Date : February 2015
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : June 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hyperglycemia

Arm Intervention/treatment
Active Comparator: Subjects with Type 2 Diabetes
Type 2 DM subjects with HbA1C > 7.5% treated with metformin, sulfonylurea, insulin or combination
Other: 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

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

Active Comparator: Non-Diabetic Obese
Age-matched, non-diabetic obese (BMI > 30 kg/m^3) individuals
Other: 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

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

Active Comparator: Lean, healthy control subjects
Age-matched, lean, healthy control subjects (BMI < 25 kkg/m^3)
Other: 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

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




Primary Outcome Measures :
  1. Metabolite Measurements by MRS [ Time Frame: 4 hours post hyperglycemia ]
    metabolite levels will be measured by MRS


Secondary Outcome Measures :
  1. Hunger Ratings [ Time Frame: 4 hours post hyperglycemia ]
    Hunger will be measured using a visual analog scale

  2. Satiety Ratings [ Time Frame: 4 hours post hyperglycemia ]
    Satiety will be measured using a visual analog scale

  3. Cognitive State [ Time Frame: 4 hours post hyperglycemia ]
    Participants will be asked to complete basic cognitive testing using the mini-mental status exam and the Montreal cognitive assessment


Other Outcome Measures:
  1. Cerebrospinal fluid cell count [ Time Frame: 2 weeks post MRS testing ]
    Metabolite levels will be measure in collected spinal fluid

  2. protein levels [ Time Frame: 2 weeks post MRS testing ]
    Metabolite levels will be measure in collected spinal fluid



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02272556


Contacts
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Contact: Janice Hwang, MD 203-785-6222 janice.hwang@yale.edu

Locations
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United States, Connecticut
Yale University Recruiting
New Haven, Connecticut, United States, 06519
Contact: Janice Hwang, MD    203-785-6222    janice.hwang@yale.edu   
Sponsors and Collaborators
Yale University
Investigators
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Principal Investigator: Robert Sherwin, MD Yale University

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Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT02272556    
Other Study ID Numbers: 1408014461
First Posted: October 23, 2014    Key Record Dates
Last Update Posted: January 14, 2019
Last Verified: January 2019
Additional relevant MeSH terms:
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Hyperglycemia
Glucose Metabolism Disorders
Metabolic Diseases