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Serum FFA Desaturase Activity Index in Patients on High Dose Corticosteroids (FFA&steroids)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02872584
Recruitment Status : Unknown
Verified August 2016 by Irit HOCHBERG MD, Rambam Health Care Campus.
Recruitment status was:  Not yet recruiting
First Posted : August 19, 2016
Last Update Posted : August 19, 2016
Information provided by (Responsible Party):
Irit HOCHBERG MD, Rambam Health Care Campus

Brief Summary:
Free fatty acid index will be measured in patients before and 1 month after high dose prednisone.

Condition or disease Intervention/treatment
Glucocorticoid Drug: Prednisone

  Show Detailed Description

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Study Type : Observational
Estimated Enrollment : 20 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Serum Free Fatty Acids Desaturase Activity Indices in Sera of Patients on Long-term High-dose Corticosteroid Treatment
Study Start Date : September 2016
Estimated Primary Completion Date : September 2017
Estimated Study Completion Date : September 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Steroids
Drug Information available for: Prednisone

Group/Cohort Intervention/treatment
Patients with dermatological conditions requiring high dose long term glucocorticoid treatment
Drug: Prednisone
prednisone treatment as required by dermatological condition (pemphigus/pemphigoid)

Primary Outcome Measures :
  1. free fatty acid quantification [ Time Frame: 1 month ]

Secondary Outcome Measures :
  1. insulin resistance [ Time Frame: 1 month ]
  2. weight gain [ Time Frame: 1 month ]

Biospecimen Retention:   Samples Without DNA

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
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.

Inclusion Criteria:

  • 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).

Exclusion Criteria:

  • 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

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Responsible Party: Irit HOCHBERG MD, Attending Physican, Institute of Diabete Endocrinology and Metabolism, Rambam Health Care Campus Identifier: NCT02872584     History of Changes
Other Study ID Numbers: 0134-16-RMB CTIL
First Posted: August 19, 2016    Key Record Dates
Last Update Posted: August 19, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Additional relevant MeSH terms:
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Anti-Inflammatory Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents