FibroblastsNCT00340912
Use of Biopsy Punch for Skin Biopsies for Fibroblasts Culturing
An observational study of Fibroblasts, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at 1 site in United States.
Trial summary
Fibroblasts can be cultured from human skin biopsies using fetal bovine serum and artificial growth medium. Fibroblasts cultured in this way retain the genetic characteristics of their donor but can be used for experiments where study conditions are much more precisely controlled than they can be in in vivo studies. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Fibroblasts
- How many people
- 500 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Dec 1988to 7 Dec 1988
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- We will include Pima Indians who do not meet any of the exclusion criteria.
Who cannot join
- We will exclude any seriously ill individuals, any known to have a bleeding diathesis or to be immunosuppressed or subjects who are carriers of HIV or HBV.
- Children will be excluded, as the age range for this study's participants is 18-50.
- Pregnant women will be excluded on the basis of a urinary pregnancy test.
- All other subjects are potentially included.
Trial locations and contacts
1 site in 1 country.
About this study
Fibroblasts can be cultured from human skin biopsies using fetal bovine serum and artificial growth medium. Fibroblasts cultured in this way retain the genetic characteristics of their donor but can be used for experiments where study conditions are much more precisely controlled than they can be in in vivo studies. We plan to culture fibroblasts from Pima Indians for two purposes. Firstly, to look for an in vitro system to measure insulin resistance, the underlying abnormality in Pima diabetics. Secondly, to look for biochemical markers of diabetes or obesity in Pimas employing two dimensional electrophoresis techniques.
Read the detailed description
Fibroblasts can be cultured from human skin biopsies using fetal bovine serum and artificial growth medium. Fibroblasts cultured in this way retain the genetic characteristics of their donor but can be used for experiments where study conditions are much more precisely controlled than they can be in in vivo studies. We plan to culture fibroblasts from Pima Indians for two purposes: 1) to look for an in vitro system to measure insulin resistance, the underlying abnormality in Pima diabetics; and 2) to look for biochemical markers of diabetes or obesity in Pimas employing two-dimensional electrophoresis techniques.
- Conditions
- Fibroblasts
- Keywords
- Skin Biopsy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2006 (estimated)
- Study start7 Dec 1988
- Primary completion7 Dec 1988
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FibroblastsStudies of the same condition, open and under way.
- More trials run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Enrolment
- 500 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00340912
- Sponsor's protocol ID
- 9999880215
- Other IDs
- OH88-DK-0215
- Status last verified
- 1 Oct 2009
- First submitted
- 19 Jun 2006
- Last updated
- 2 Jul 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Biopsy Punch for Skin Biopsies for Fibroblasts Culturing
- ClinicalTrials.gov ID
- NCT00340912
- Acronym / sponsor ID
- 9999880215
- Conditions
- Fibroblasts
- Keywords
- Skin Biopsy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 500 participants
- Lead sponsor
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)US National Institutes of Health
- Study start
- 7 Dec 1988
- Primary completion
- 7 Dec 1988 (actual)
- First posted
- 21 Jun 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Fibroblasts can be cultured from human skin biopsies using fetal bovine serum and artificial growth medium. Fibroblasts cultured in this way retain the genetic characteristics of their donor but can be used for experiments where study conditions are much more precisely controlled than they can be in in vivo studies. We plan to culture fibroblasts from Pima Indians for two purposes. Firstly, to look for an in vitro system to measure insulin resistance, the underlying abnormality in Pima diabetics. Secondly, to look for biochemical markers of diabetes or obesity in Pimas employing two dimensional electrophoresis techniques.
Detailed description
Fibroblasts can be cultured from human skin biopsies using fetal bovine serum and artificial growth medium. Fibroblasts cultured in this way retain the genetic characteristics of their donor but can be used for experiments where study conditions are much more precisely controlled than they can be in in vivo studies. We plan to culture fibroblasts from Pima Indians for two purposes: 1) to look for an in vitro system to measure insulin resistance, the underlying abnormality in Pima diabetics; and 2) to look for biochemical markers of diabetes or obesity in Pimas employing two-dimensional electrophoresis techniques.
Study design
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- We will include Pima Indians who do not meet any of the exclusion criteria.
Key exclusion criteria (4 listed)
- We will exclude any seriously ill individuals, any known to have a bleeding diathesis or to be immunosuppressed or subjects who are carriers of HIV or HBV.
- Children will be excluded, as the age range for this study's participants is 18-50.
- Pregnant women will be excluded on the basis of a urinary pregnancy test.
- All other subjects are potentially included.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fibroblasts, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2017.