Prolonged Fasting and FGF-21 Levels - Full Text View

Sponsor:	Beth Israel Deaconess Medical Center
Information provided by:	Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier:	NCT00968747

Purpose

This study will look at the effect of 72 hours of fasting (not eating) on levels of proteins that are involved in metabolism. These proteins will be measured in blood and fat tissue. The investigators' hypothesis is that fasting will cause changes in these proteins.

Condition	Intervention
Metabolism Fasting	Behavioral: Fasting

Study Type:	Interventional
Study Design:	Open Label, Single Group Assignment
Official Title:	The Effect of Prolonged Fasting on FGF-21 Levels in Healthy Adults

Resource links provided by NLM:

MedlinePlus related topics: Diets

U.S. FDA Resources

Further study details as provided by Beth Israel Deaconess Medical Center:

Primary Outcome Measures:

Fibroblast Growth Factor 21 levels in serum and fat [ Time Frame: prior to fasting and at the end of the 72-hour fast ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Polymerase 1 and Transcript Release Factor levels in fat [ Time Frame: prior to fasting and at the end of the 72-hour fast ] [ Designated as safety issue: No ]
Urine and serum ketosis [ Time Frame: daily during the 72-hour fast ] [ Designated as safety issue: No ]

Estimated Enrollment:	40
Study Start Date:	July 2009
Estimated Study Completion Date:	August 2010
Estimated Primary Completion Date:	August 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Fasting: Experimental Participants will fast for 72 hours during an inpatient stay at the Beth Israel Deaconess Medical Center in Boston, MA. During the fast, participants will receive only water and vitamins. Blood samples will be collected daily and two fat samples will be obtained by a trained surgeon.	Behavioral: Fasting Participants will fast for 72 hours and may consume only water and vitamins.

Detailed Description:

The purpose of this study is to examine how fasting affects levels of several proteins involved in metabolism. Studies done in animals show that fasting causes changes in proteins involved in fatty acid metabolism and the structure of fat cells. In this study, we wish to learn whether these factors change when humans are fasted.

This study will involve a 72 hour fast. During the fast, study participants may consume only water and vitamins. Participants will spend 3 days and nights in the Clinical Research Center at the Beth Israel Deaconess Medical Center. Daily blood samples will be taken, as well as two fat samples, one before the fast and one at the end of the fast.

Eligibility

Ages Eligible for Study:	18 Years to 50 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Age 18-50 years
Body Mass Index 21-26 kg/m^2
Ability to give informed consent
Ability to follow verbal and written instructions in English

Exclusion Criteria:

Type 1 or Type 2 diabetes mellitus diagnosed according to the American Diabetes Association criteria
Coronary heart disease (history of myocardial infarction, unstable angina pectoris, or congestive heart failure)
Tobacco, marijuana, or intravenous drug use within 1 year of screening visit
Recent weight change (>3 kg within 6 months of screening visit)
Malignancy treated with chemotherapy within past 3 years
History of depression, psychosis, or other psychiatric illness requiring hospitalization
History of hyperthyroidism
Renal insufficiency (creatinine clearance < 50 ml/min)
Transaminases > 2X above the normal range
Known liver disease
Pregnancy within 12 months of screening visit
Lactation within 12 months of screening visit
Failure to use medically approved contraceptive methods (oral contraceptive, 2 barrier methods, surgical sterilization)
History of an eating disorder (anorexia, bulimia, or laxative abuse)
History of surgery for the treatment of obesity (gastric banding, gastric bypass, gastric stapling)
New diagnosis of hypothyroidism within 1 year of screening visit or change in dose of thyroid hormone within 3 months of screening visit
History of alcohol abuse within the past 3 years
History of keloid formation
History of allergy to lidocaine or marcaine
Use of plavix, coumadin, or heparin

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00968747

Contacts

Contact: Meghan Crawley, MS	617-735-3281	mcrawley@bidmc.harvard.edu
Contact: Jody Dushay, MD	617-735-3281	jdushay@bidmc.harvard.edu

Locations

United States, Massachusetts
Beth Israel Deaconess Medical Center	Recruiting
Boston, Massachusetts, United States, 02215
Sub-Investigator: Eleftheria Maratos-Flier, MD
Sub-Investigator: Daniel Jones, MD
Sub-Investigator: Benjamin Schneider, MD
Sub-Investigator: Patricia Chui, MD, PhD
Sub-Investigator: Meghan Crawley, MS

Sponsors and Collaborators

Beth Israel Deaconess Medical Center

Investigators

Principal Investigator:

Jody Dushay, MD

Beth Israel Deaconess Medical Center

More Information

No publications provided

Responsible Party:	Beth Israel Deaconess Medical Center ( Jody Dushay, MD )
Study ID Numbers:	2009P-000073
Study First Received:	July 31, 2009
Last Updated:	August 28, 2009
ClinicalTrials.gov Identifier:	NCT00968747 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Beth Israel Deaconess Medical Center:

Fasting
Fast
Metabolism
healthy
diet
study
manipulation
dietary

FGF21
Fibroblast growth factor
PTRF
Polymerase 1 and transcript release factor
adipose
fat
blood
inpatient

ClinicalTrials.gov processed this record on February 08, 2010