Insulin Deprivation on Brain Structure and Function in Humans With Type 1 Diabetes

NCT03392441 | Completed

• 1 other identifier: 17-005244
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

What are the effects of transient insulin deprivation on brain structure, blood flow, mitochondrial function, and cognitive function in T1DM patients? What are the effects of transient insulin deprivation on circulating exosomes and metabolites in T1DM patients?

Conditions

Diabetes Mellitus, Type 1; Diabetes; Diabetes Complications

Keywords

dementia; cognition; insulin; adolescent

Outcome Measures

Primary Outcomes (1)

• Change in Structural MRI

  Structural magnetic resonance imaging (MRI) is a non-invasive technique for examining the anatomy and pathology of the brain (as opposed to using functional magnetic resonance imaging \[fMRI\] to examine brain activity. This produces images which can be used for clinical radiological reporting as well as for detailed analysis.

  baseline, 6 hours

Study Arms (1)

Insulin Deprivation

EXPERIMENTAL

Insulin Deprivation in Type 1 Diabetic Patients will be performed for a short time period (4-6 hours). Changes to Age, Sex, and Gender matched controls will be compared.

Other: Insulin Deprivation in Type 1 Diabetic Patients

Interventions

Insulin Deprivation in Type 1 Diabetic Patients OTHER

Type 1 Diabetic Patients requiring insulin will have insulin stopped for a short period of time (4-6 hours)

Insulin Deprivation

Eligibility Criteria

• Age: 14 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Male and females age 14-17 years, females must be post-menarcheal
• Age 18-45 years
• Able to provide written consent
• Parents able to provide written consent
• T1DM treated with CSII or MDI (not degludec)

You may not qualify if:

• BMI \< 20 or \> 30 kg/m2
• BMI z-score \<5th or \>95th percentile
• Celiac disease
• Pregnancy
• Smoking
• Reported history of illicit substance use
• History of active cardiovascular, cerebrovascular, or peripheral vascular disease
• Active renal disease evidenced by estimated GFR \< 50 mL/min/1.73 m2
• History of traumatic brain injury
• Dementia or any other neurologic disease
• Psychiatric disease\\
• Any learning disability
• Hemoglobin A1c \> 8.5%
• Hemoglobin A1c \> 9%
• T2DM, or impaired fasting glucose

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Publications (1)

• Creo AL, Cortes TM, Jo HJ, Huebner AR, Dasari S, Tillema JM, Lteif AN, Klaus KA, Ruegsegger GN, Kudva YC, Petersen RC, Port JD, Nair KS. Brain functions and cognition on transient insulin deprivation in type 1 diabetes. JCI Insight. 2021 Mar 8;6(5):e144014. doi: 10.1172/jci.insight.144014.

  PMID: 33561011 DERIVED

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Diabetes Mellitus; Diabetes Complications; Dementia; Insulin Resistance

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders; Hyperinsulinism

Study Officials

• K Sreekumaran Nair

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant Endocrinology and Metabolism

Study Record Dates

• First Submitted: December 13, 2017
• First Posted: January 8, 2018
• Study Start: November 30, 2017
• Primary Completion: August 1, 2018
• Study Completion: July 5, 2019
• Last Updated: February 3, 2022

Record last verified: 2022-02

Locations

US (1)