A Pilot Feasibility Study of Fibroblast Calcium and Glucoregulation in Health and Disease
A Pilot Feasibility Study of Fibroblast Calcium and Glucoregulation in Health
Studieoversikt
Status
Forhold
Detaljert beskrivelse
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.
Studietype
Kontakter og plasseringer
Studiesteder
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Kentucky
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Lexington, Kentucky, Forente stater, 40536
- University of Kentucky Center for Clinical and Translational Science
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
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Lean Non-Diabetic Group
Variables measured will also include serum analyses (HbA1c, adiponectin, cholesterol) and patient vital signs.
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Pre-diabetics
These patients are anticipated to have elevated BMI, yet not be diabetics.
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Diabetic Patients
These patients will have good glucose control.
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Diabetic patients with poor glucocontrol
These patients are anticipated to have poor glucose control.
They are usually taking insulin.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Are peak (nM) calcium responses to bradykinin enhanced along the continuum of disease in skin fibroblasts from the 4 patient groups?
Tidsramme: Three years
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All participants groups will be compared statistically to the lean patient group.
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Three years
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Are glucose utilization rates (a.u./min) measured in skin fibroblasts from the 4 patient groups different with disease progression?
Tidsramme: Three years
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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.
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Three years
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Andre resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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What component of peripheral metabolic dysregulation (HbA1c (%), adiponectin (ug/mL), cholesterol (mg/dL)) is associated with changes in calcium responses (nM) in skin fibroblasts?
Tidsramme: Three years
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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.
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Three years
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Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Etterforskere
- Studieleder: Olivier Thibault, PhD, University of Kentucky
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Forventet)
Studiet fullført (Forventet)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Andre studie-ID-numre
- 13-0571-F1V
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