Impact of Hypoglycemia Unawareness on Brain Metabolism Cognition in T1DM

NCT00575783 | Completed DMC

• 3 other identifiers: 0505000077_BR01DK072409HIC# 0505000077
• Study Type: observational
• Target: 51
• Locations: 1 country
• Sites: 1

Brief Summary

The research study is designed to examine the impact of low blood sugar on brain function in individuals with Type 1 Diabetes who have frequent and severe hypoglycemia (low blood sugar) compared to those who do not.

Conditions

Type 1 Diabetes; Hypoglycemia

Keywords

type 1 diabetes; hypoglycemia; magnetic resonance imaging

Study Arms (3)

1A, 1B

Type 1 diabetic subjects with a history of severe hypoglycemia and hypoglycemia unawareness who: 1A) meet criteria for islet cell transplantation and are referred by a participating islet cell transplantation center 1B) meet similar criteria but are not currently planning islet cell transplantation

2

Type 1 diabetics who are not optimally controlled (\>8% HbA1c) and rarely experience hypoglycemia

3

Healthy non-diabetics

Eligibility Criteria

• Age: 18 Years - 49 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Group 1A) T1DM subjects with severe hypoglycemia unawareness and awaiting islet cell transplantation will be referred by participating islet transplantation centers. Group 1B) T1DM subjects with severe hypoglycemia unawareness but not awaiting islet cell transplantation will be from the greater New Haven, CT area. Group 2)T1DM, not optimally controlled and without hypoglycemia unawareness will be from the greater New Haven, CT area. Group 3) Non-Diabetics from the greater New Haven CT area.

You may qualify if:

• Age 18-49
• \> 85 kg
• BMI \<27female \<28 male
• able to provide written informed consent
• able to speak and read English fluently
• must meet Magnetic Resonance safety evaluation
• T1DM undergoing intensive clinical management and currently on the islet transplant list
• History of severe hypoglycemia
• T1DM undergoing intensive clinical management
• History of severe hypoglycemia unawareness
• T1DM with poor glycemic control, HbA1c \> 8%
• no episodes of hypoglycemia requiring assistance from another person for at least 1 yr, no episodes in last 4 weeks, and hypoglycemia aware

You may not qualify if:

• Group 1A: (T1DM subjects being considered for islet cell transplantation)
• Detectable c-peptide level
• Untreated proliferative retinopathy
• Creatinine clearance \< 65 ml/min/1.73 m2
• Serum creatinine ≥1.5 mg/dL
• Previous pancreas or islet transplant
• Positive pregnancy test, or presently breast-feeding, or failure to follow effective contraceptive measures
• Active infection including hepatitis C, hepatitis B, HIV, or TB (or under treatment for suspected TB ), or subjects with a positive PPD performed within 1 yr. of enrollment, and no history of adequate prophylaxis
• Invasive aspergillus infection within year prior to study entry
• Any history of malignancy except for adequately treated squamous or basal cell carcinoma of the skin
• Active alcohol or substance abuse- includes cigarette smoking (must be abstinent for 6 months)
• History of non-adherence to prescribed regimens
• Psychiatric disorder making the subject not a suitable candidate for transplantation
• Baseline Hgb \< 10.5 g/dL in females, or \< 13 g/dL in males; lymphopenia (\<1,000/μL), or leukopenia (\< 3,000 total leukocytes/μL), or an absolute CD4+ count \< 500/μL
• History of coagulopathy or medical condition requiring long-term anticoagulant therapy (e.g., warfarin) after transplantation (low-dose aspirin treatment is allowed) or patient with INR \>1.5

Sponsors & Collaborators

• Yale University: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator
• University of Miami: collaborator
• University of Minnesota: collaborator

Study Sites (1)

Yale University School of Medicine

New Haven, Connecticut, 06520, United States

Location

Related Links

• American Diabetes Association
• Juvenile Diabetes Research Foundation

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Hypoglycemia

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Robert Sherwin, MD

  Yale University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 14, 2007
• First Posted: December 18, 2007
• Study Start: August 1, 2005
• Study Completion: August 1, 2008
• Last Updated: April 2, 2020

Record last verified: 2020-03

Locations

US (1)