"Tissue-Specific Metabolic Reprogramming in Diabetic Complications. Glycemic Clamp Studies to Determine the Real Time Synthesis Rates of Glucose Derived Metabolites in Individuals With Type 1 Diabetes and Healthy Controls"

IRB Number: HUM00060967

Principal Investigator: Dr. Rodica Pop-Busui
Study Coordinator: Cindy Plunkett, 734-936-8065 or cplunket@umich.edu

Purpose: To assess steady state and dynamic metabolite changes in subjects with type 1 diabetes with and without microvascular complications and to understand differences from non-diabetics in metabolite levels and flux.

Study Description: The hypothesis is that diabetic complications arise from tissue-specific metabolic reprogramming resulting in alterations in fuel utilization that lead to dysfunction of the tissue. To test this hypothesis, we will use sensitive and specific mass-spectrometer-based metabolomic analysis to measure steady-state metabolite levels in plasma and urine from controls subjects and subjects with T1DM, without and with diabetic complications, during euglycemic and hyperglycemic clamp studies.

Group 1: T1DM subjects without complications
Group 2: T1DM subjects with microalbuminuria (early kidney disease)
Group 3: T1DM subjects with advanced diabetes complications
Group 4: Age-and-sex-matched healthy control subjects

ELIGIBILITY CRITERIA:

• Must have type 1 diabetes of less than 5 years' duration.
• 18 years of age or older.
• Subjects in the microalbuminuria group (Group 2) will have a history of urinary microalbumin to creatinine ratio between 30-300 m/g confirmed on repeat testing while the non-albuminuric group will have a value of less than 30 mg/g.
• Subjects in the advanced complications group (Group 3) will have confirmed retinopathy, peripheral and/or autonomic neuropathy and nephropathy. 
• Healthy volunteers will be matched for age and gender and will have normal glucose tolerance, normal lipid metabolism, and normal blood pressure.
  

EXCLUSION CRITERIA:

Subjects may not:

• Be less than 18 years old.
• Be women of child-bearing potential who may be pregnant or lactating
• Have history of pancreas, kidney or liver transplant
• Have history of drug or alcohol use.
• Have history of cancer other than basal cell carcinoma or squamous cell skin cancer.
• Have the a condition that, in the opinion of the investigator, would make it unlikely for the subject to complete the study.

Compensation: $350 for successful completion of the study.

"Cardiac Autonomic Neuropathy and Myocardial Dysfunction in Type 1 Diabetes"

IRB #: HUM00036408   
(click on the IRB# to see the full study description in the UM Clinical Studies Database)

Principal Investigator: Dr. Rodica Pop-Busui
Study Coordinator: Cindy Plunkett, 734-936-8065 or cplunket@umich.edu

ELIGIBILITY CRITERIA:

• Age range: 18–65 years old
• This study is seeking: Patients with specified condition (type 1 diabetes)
• No complications associated with diabetes
• Type 1 diabetes diagnosed at least 5 yrs

Other eligibility factors:

• Gender: Male & Female
• Ethnicity: All
• Race: All
• Smoking: Both Smoking and Non Smoking Volunteers
• Medication: Taking Medication

Compensation: $50.00 for completed imaging tests, $25 each for all other completed visits

"Type 1 Diabetes TrialNet Natural History Studies"

IRB#: HUM00011027
(click on the IRB# to see full study description in the UM Clinical Studies Database)

Principal Investigator: Massimo T. Pietropaolo, MD
Study Coordinator: Cathy Martin, MS, APRN, BC-ADM, CDE, 734-936-6465 or martinc@umich.edu

ELIGIBILITY CRITERIA:

• Age range: 1–45 years old
• This study is seeking: Healthy subjects

Other eligibility factors:

• Ages 1 to 18 with second-degree relative with type 1 diabetes
• Ages 1 to 45 with first-degree relative with type 1 diabetes
• Family history of type 1 diabetes

Compensation: None (over 10,000 people are being recruited for the study)