A Pilot Feasibility Study of Fibroblast Calcium and Glucoregulation in Health and Disease
A Pilot Feasibility Study of Fibroblast Calcium and Glucoregulation in Health
Visão geral do estudo
Status
Condições
Descrição detalhada
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.
Tipo de estudo
Contactos e Locais
Locais de estudo
-
-
Kentucky
-
Lexington, Kentucky, Estados Unidos, 40536
- University of Kentucky Center for Clinical and Translational Science
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Método de amostragem
População do estudo
Descrição
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
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
Coortes e Intervenções
Grupo / Coorte |
|---|
|
Lean Non-Diabetic Group
Variables measured will also include serum analyses (HbA1c, adiponectin, cholesterol) and patient vital signs.
|
|
Pre-diabetics
These patients are anticipated to have elevated BMI, yet not be diabetics.
|
|
Diabetic Patients
These patients will have good glucose control.
|
|
Diabetic patients with poor glucocontrol
These patients are anticipated to have poor glucose control.
They are usually taking insulin.
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Are peak (nM) calcium responses to bradykinin enhanced along the continuum of disease in skin fibroblasts from the 4 patient groups?
Prazo: Three years
|
All participants groups will be compared statistically to the lean patient group.
|
Three years
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Are glucose utilization rates (a.u./min) measured in skin fibroblasts from the 4 patient groups different with disease progression?
Prazo: 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.
|
Three years
|
Outras medidas de resultado
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
What component of peripheral metabolic dysregulation (HbA1c (%), adiponectin (ug/mL), cholesterol (mg/dL)) is associated with changes in calcium responses (nM) in skin fibroblasts?
Prazo: 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.
|
Three years
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Diretor de estudo: Olivier Thibault, PhD, University of Kentucky
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
Conclusão Primária (Antecipado)
Conclusão do estudo (Antecipado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Outros números de identificação do estudo
- 13-0571-F1V
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .