Type 2 Diabetes
Conditions
Brief summary
The purpose of this research is to better understand how calcium and glucose may play a role in people developing diabetes. By doing this study, the investigator hopes to learn whether abnormal calcium and glucose responses in skin biopsies from healthy patients and patients with Type 2 diabetes can identify and predict patients at greatest risk for later complications.
Detailed description
The overall goal of this proposal is to establish a pathophysiological index of a patient's status through imaging of calcium and glucose in skin fibroblasts. The investigator will obtain skin samples from patients in the Barnstable Brown Obesity and Diabetes Center at the University of Kentucky to test the hypothesis that calcium and glucose dysregulation are present in fibroblasts from patients with Type 2 diabetes, and are exaggerated in more difficult-to-treat patients or those with poor glucose control. The innovation of the project focuses on results that can potentially lead to earlier treatment for patients with diabetes and thereby reduce the risk for long-term complications. Three levels of analyses will be conducted to assess the relationship between Ca2+ and glucose homeostasis in four patient groups (lean non-diabetics, obese non-diabetics, Type 2 Diabetics with good glucose control, and Type 2 Diabetics with poor control. Participants will be required to attend only one study visit that will last approximately 2-3 hours. During the study subject will undergo the following: 1. Collection of two 4 ml tubes of blood for adiponectin analysis, 2. A skin biopsy, 3. Collection and review of medical history and current/past medication use 4. Collection of demographic information, 5. Height and weight measurement 6. Body mass index evaluation, 7. Vital signs assessment (blood pressure, pulse). Follow-up for all enrolled patients will occur on a yearly basis through a phone interview. The punch biopsy will be performed under local anesthesia.
Interventions
None listed
Sponsors
American Diabetes Association
University of Kentucky
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
40 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy * Type 2 Diabetes
Exclusion criteria
* Under 40 years of age * Over 55 years of age * Pregnant or breastfeedig * Will not agree to a skin biopsy * Talking calcium channel blockers
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Are peak (nM) calcium responses to bradykinin enhanced along the continuum of disease in skin fibroblasts from the 4 patient groups? | Three years | All participants groups will be compared statistically to the lean patient group. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Are glucose utilization rates (a.u./min) measured in skin fibroblasts from the 4 patient groups different with disease progression? | Three years | A unitless index of health status based on serum analyses (cholesterol, adiponectin, HbA1c) for each patient will be correlated with a unitless index of glucose status based on fibroblast imaging data. |
Other
| Measure | Time frame | Description |
|---|---|---|
| What component of peripheral metabolic dysregulation (HbA1c (%), adiponectin (ug/mL), cholesterol (mg/dL)) is associated with changes in calcium responses (nM) in skin fibroblasts? | Three years | The investigator will also focus on two groups of patients, obese-non-diabetics and diabetics with poor control, during the analysis period and prospectively follow these patients for clinical outcomes. |
Countries
United States
Outcome results
None listed