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

Hyperglycemia Clinical Trial

Official title:

Investigating the Role of Polyol Pathway in the Central Nervous System

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02272556
• Other study ID #: 1408014461
• Status: Completed
• Phase: N/A
• Start date: February 2015
• Est. completion date: May 18, 2022

Study information

• Verified date: August 2022
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 138
• Est. completion date: May 18, 2022
• Est. primary completion date: May 18, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Hyperglycemia

Intervention

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

Locations

Country	Name	City	State
United States	Yale University	New Haven	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
Yale University	American Diabetes Association

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Cerebrospinal fluid cell count	Metabolite levels will be measure in collected spinal fluid	2 weeks post MRS testing
Other	protein levels	Metabolite levels will be measure in collected spinal fluid	2 weeks post MRS testing
Primary	Metabolite Measurements by MRS	metabolite levels will be measured by MRS	4 hours post hyperglycemia
Secondary	Hunger Ratings	Hunger will be measured using a visual analog scale	4 hours post hyperglycemia
Secondary	Satiety Ratings	Satiety will be measured using a visual analog scale	4 hours post hyperglycemia
Secondary	Cognitive State	Participants will be asked to complete basic cognitive testing using the mini-mental status exam and the Montreal cognitive assessment	4 hours post hyperglycemia