Serum FFA Desaturase Activity Index in Patients on High Dose Corticosteroids
FFA&steroids
Serum Free Fatty Acids Desaturase Activity Indices in Sera of Patients on Long-term High-dose Corticosteroid Treatment
1 other identifier
observational
20
0 countries
N/A
Brief Summary
Free fatty acid index will be measured in patients before and 1 month after high dose prednisone.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Sep 2016
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 16, 2016
CompletedFirst Posted
Study publicly available on registry
August 19, 2016
CompletedStudy Start
First participant enrolled
September 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2018
CompletedAugust 19, 2016
August 1, 2016
1 year
August 16, 2016
August 18, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
free fatty acid quantification
1 month
Secondary Outcomes (2)
insulin resistance
1 month
weight gain
1 month
Study Arms (1)
Prednisone
Patients with dermatological conditions requiring high dose long term glucocorticoid treatment
Interventions
prednisone treatment as required by dermatological condition (pemphigus/pemphigoid)
Eligibility Criteria
About 20 consecutive eligible patients diagnosed with pemphigus or bullous pemphigoid, who are planned to be placed on a high dose oral corticosteroid regimen (equivalent to 0.5mg/kg/day or more of prednisone) for at least one month, will be recruited.
You may qualify if:
- Each participant must be at least 18 years of age.
- Each participant must give a written informed consent for participation in the study.
- Each participant must be drug naïve with respect to previous glucocorticoid treatment (history of less than 2-week treatment at any time is authorized, but with no recent glucocorticoid therapy over 3 months before study entry).
You may not qualify if:
- Obese subjects, defined as BMI \> 35 or underweight subjects, defined as BMI \< 18.5
- A history of eating disorder
- Diabetes mellitus
- A history of Cushing's syndrome, subclinical hypercortisolism, hypoadrenalism, or congenital adrenal hyperplasia
- Abnormal thyroid function test : history of hyperthyroidism or hypothyroidism
- Active cancer
- Uncontrolled hypertension \>160/95
- Hypercholesterolemia, defined as LDL \> 190
- Hypertriglyceridemia, defined as TG \> 250
- Acute or Chronic renal failure (GFR \< 45) or nephrotic syndrome
- Acute or chronic hepatitis or cirrhosis
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Biospecimen
serum
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Attending Physican, Institute of Diabete Endocrinology and Metabolism
Study Record Dates
First Submitted
August 16, 2016
First Posted
August 19, 2016
Study Start
September 1, 2016
Primary Completion
September 1, 2017
Study Completion
September 1, 2018
Last Updated
August 19, 2016
Record last verified: 2016-08
Data Sharing
- IPD Sharing
- Will share