- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT01917669
A Pilot Feasibility Study of Fibroblast Calcium and Glucoregulation in Health and Disease
A Pilot Feasibility Study of Fibroblast Calcium and Glucoregulation in Health
Studieöversikt
Status
Betingelser
Detaljerad beskrivning
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.
Studietyp
Kontakter och platser
Studieorter
-
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Kentucky
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Lexington, Kentucky, Förenta staterna, 40536
- University of Kentucky Center for Clinical and Translational Science
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
Beskrivning
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
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / 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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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Are peak (nM) calcium responses to bradykinin enhanced along the continuum of disease in skin fibroblasts from the 4 patient groups?
Tidsram: Three years
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All participants groups will be compared statistically to the lean patient group.
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Three years
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Are glucose utilization rates (a.u./min) measured in skin fibroblasts from the 4 patient groups different with disease progression?
Tidsram: 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.
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Three years
|
Andra resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
What component of peripheral metabolic dysregulation (HbA1c (%), adiponectin (ug/mL), cholesterol (mg/dL)) is associated with changes in calcium responses (nM) in skin fibroblasts?
Tidsram: 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
|
Samarbetspartners och utredare
Sponsor
Samarbetspartners
Utredare
- Studierektor: Olivier Thibault, PhD, University of Kentucky
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Förväntat)
Avslutad studie (Förväntat)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Andra studie-ID-nummer
- 13-0571-F1V
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