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Completed

NCT Number: NCT02272556

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

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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Key information

Conditions

Hyperglycemia Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Yale University

New Haven, Connecticut, 06519, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Brain MRS during hyperglycemic clamp

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

Other

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

Primary outcomes

  1. Metabolite Measurements by MRS

    Time frame: 4 hours post hyperglycemia

    metabolite levels will be measured by MRS

Secondary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Yale University

Other

Collaborators

  • American Diabetes Association

Registry information

Official study title

Investigating the Role of Polyol Pathway in the Central Nervous System

Important dates

Study start
2015
Primary completion
2022
Study completion
2022
First posted
Oct 23, 2014
Registry last updated
Aug 18, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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