Impact of Hypoglycemia Unawareness on Brain Metabolism Cognition in T1DM

Completed

Conditions studied: Type 1 Diabetes, Hypoglycemia

In brief

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.

Key facts

Study ID

NCT00575783

Run by

Yale University

People needed

51

Starts

2005-08-01

Expected to finish

2008-08-01

Last updated by the study team

2020-04-02

Who can join

Age: 18 and older, up to 49. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Inclusion Criteria for all subjects:
• 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
• Inclusion criteria for Group 1A:
• T1DM undergoing intensive clinical management and currently on the islet transplant list
• History of severe hypoglycemia
• Inclusion criteria for Group 1B:
• T1DM undergoing intensive clinical management
• History of severe hypoglycemia unawareness
• Inclusion criteria for Group 2:
• 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
• Severe co-existing cardiac disease, as determined by referring center
• Baseline liver function tests outside of normal range (an initial liver function test panel with any values >1.5 times normal upper limits will exclude a patient without a re-test; a re-test for any values between normal and 1.5 times normal will be made, and if the values remain elevated above normal, the patient will be excluded), or history of significant liver disease
• Severe unremitting diarrhea or other gastrointestinal disorders potentially interfering with the ability to absorb oral medications
• Addison's disease as determined by clinical history
• Under treatment for a medical condition requiring chronic use of systemic steroids
• Any medical condition or medication that, in the opinion of the investigators, will interfere with the safe completion of the study or study outcomes
• Group 1 B: (T1DM with Severe Hypoglycemia Unawareness not on the Transplant List)
• Detectable C-peptide level
• Serum creatinine ≥1.5 mg/dL
• Positive pregnancy test, or presently breast-feeding, or failure to follow effective contraceptive measures

Where it is running

• Yale University School of Medicine — New Haven, Connecticut, United States

Full record on ClinicalTrials.gov

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