HealthyNCT01257841
Secondary Analysis of Gut Hormones and Inflammatory Cytokines in Fasting Subjects
A study testing Leptin administration and Fasting in people with Healthy, run by Massachusetts General Hospital at 2 sites in United States.
Trial summary
The original study executed between 2002-2004 was an interventional trial in which 20, healthy, normal-weight female subjects were randomized to a four-day fast plus daily subcutaneous injections of leptin or a four day fast plus daily subcutaneous injections of a placebo. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Leptin administration and Fasting
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 2 sitesUnited States
- Study dates
- Nov 2002to Dec 2003
- Phase
- Interventional
- 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 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- female age 18-35
- BMI 20-26.0
- eumenorrheic with normal FSH, TSH, Prolactin
- Hgb > 12 g/dL, normal creatinine
- normal puberty and development
- negative pregnancy test. In addition, subjects agreed not to be sexually active during the course of the inpatient study and to use contraception for a period of 48 hours after discharge from the hospital.
Who cannot join
- medical or endocrine problems known to affect thyroid, reproductive, GH or cortisol function
- medications known to affect neuroendocrine function
- prior history of eating disorder or significant menstrual irregularities
- subjects who have a known hypersensitivity to E. Coli derived protein.
- subjects with a history of seizure disorder, significant cardiac disease, medication for cardiac disease, or kidney disease
- history of anaphylaxis or anaphylactoid like reactions.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Massachusetts General Hospital
Boston, Massachusetts, 02114
Massachusetts Institute of Technology
Cambridge, Massachusetts, 02139
About this study
Official title: Effects of Four-day Fast on Gut-derived Hormones and Inflammatory Markers in Healthy, Normal-weight Women.
The original study executed between 2002-2004 was an interventional trial in which 20, healthy, normal-weight female subjects were randomized to a four-day fast plus daily subcutaneous injections of leptin or a four day fast plus daily subcutaneous injections of a placebo. The primary endpoints were gonadotropin pulsatility, TSH secretion and thyroid function, and cortisol secretion. The current study is a secondary analysis focussed on the placebo group which underwent a four-day fast. The study is looking at the effects of fasting on gut-derived hormones and inflammatory markers in healthy, normal-weight women. The hypothesis for this secondary analysis was that four days of fasting would augment levels of orexigenic gut-derived hormones and suppress levels of anorexigenic gut-derived horomones, while suppressing secretion of inflammatory cytokines.
- Conditions
- Healthy
- Being tested
- Leptin administration, Fasting
- Keywords
- Fasting, Gut hormones, Inflammatory Cytokines
- Medical subject headings
- Fasting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Leptin administrationDrug
Leptin 0.05 mg/kg sc daily in divided doses (0800, 1400, 2000, and 0200h) for four days.
FastingBehavioural
Complete fasting, save for water and multivitamin, for four days.
| Study group | Role | What they receive |
|---|---|---|
| Fasting alone | Placebo comparator | Not described Receives: Behavioral: Fasting |
| Fasting plus leptin | Active comparator | Not described Receives: Drug: Leptin administration; Behavioral: Fasting |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hormone levels change from baseline.
Original study looking at gonadotropin pulsitility, TSH secretion and thyroid function, and cortisol secretion. Present study looking at gut-hormone secretion.
Measured: Change from baseline after 4 days of intervention.
Secondary outcomes (1)
Levels of inflammatory cytokines change from baseline.
Measured: Change from baseline after 4 days of intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2010 (estimated)
- Study startNov 2002
- Primary completionDec 2003
- Study completionDec 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe 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
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Massachusetts Institute of Technology
- Investigators
- Steven K Grinspoon, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01257841
- Sponsor's protocol ID
- 2002P-000518SA1
- Status last verified
- Dec 2010
- First submitted
- 7 Dec 2010
- Last updated
- 10 Dec 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Canavan B, Salem RO, Schurgin S, Koutkia P, Lipinska I, Laposata M, Grinspoon S. Effects of physiological leptin administration on markers of inflammation, platelet activation, and platelet aggregation during caloric deprivation. J Clin Endocrinol Metab. 2005 Oct;90(10):5779-85. doi: 10.1210/jc.2005-0780. Epub 2005 Aug 2.
PubMed 16076944Schurgin S, Canavan B, Koutkia P, Depaoli AM, Grinspoon S. Endocrine and metabolic effects of physiologic r-metHuLeptin administration during acute caloric deprivation in normal-weight women. J Clin Endocrinol Metab. 2004 Nov;89(11):5402-9. doi: 10.1210/jc.2004-1102.
PubMed 15531489Koutkia P, Schurgin S, Berry J, Breu J, Lee BS, Klibanski A, Grinspoon S. Reciprocal changes in endogenous ghrelin and growth hormone during fasting in healthy women. Am J Physiol Endocrinol Metab. 2005 Nov;289(5):E814-22. doi: 10.1152/ajpendo.00093.2005. Epub 2005 Jun 21.
PubMed 15972272
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Four-day Fast on Gut-derived Hormones and Inflammatory Markers in Healthy, Normal-weight Women.
- ClinicalTrials.gov ID
- NCT01257841
- Acronym / sponsor ID
- 2002P-000518SA1
- Conditions
- Healthy
- Keywords
- Fasting, Gut hormones, Inflammatory Cytokines
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- Massachusetts Institute of Technology
- Study start
- Nov 2002
- Primary completion
- Dec 2003 (actual)
- Study completion
- Dec 2003 (actual)
- First posted
- 10 Dec 2010 (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.
The original study executed between 2002-2004 was an interventional trial in which 20, healthy, normal-weight female subjects were randomized to a four-day fast plus daily subcutaneous injections of leptin or a four day fast plus daily subcutaneous injections of a placebo. The primary endpoints were gonadotropin pulsatility, TSH secretion and thyroid function, and cortisol secretion. The current study is a secondary analysis focussed on the placebo group which underwent a four-day fast. The study is looking at the effects of fasting on gut-derived hormones and inflammatory markers in healthy, normal-weight women. The hypothesis for this secondary analysis was that four days of fasting would augment levels of orexigenic gut-derived hormones and suppress levels of anorexigenic gut-derived horomones, while suppressing secretion of inflammatory cytokines.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fasting alone | Placebo comparator | Behavioral: Fasting |
| Fasting plus leptin | Active comparator | Drug: Leptin administration, Behavioral: Fasting |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- female age 18-35
- BMI 20-26.0
- eumenorrheic with normal FSH, TSH, Prolactin
- Hgb > 12 g/dL, normal creatinine
- normal puberty and development
Key exclusion criteria (6 listed)
- medical or endocrine problems known to affect thyroid, reproductive, GH or cortisol function
- medications known to affect neuroendocrine function
- prior history of eating disorder or significant menstrual irregularities
- subjects who have a known hypersensitivity to E. Coli derived protein.
- subjects with a history of seizure disorder, significant cardiac disease, medication for cardiac disease, or kidney disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Leptin administrationLeptin 0.05 mg/kg sc daily in divided doses (0800, 1400, 2000, and 0200h) for four days. | Drug | Fasting plus leptin |
| FastingComplete fasting, save for water and multivitamin, for four days. | Behavioural | Fasting alone, Fasting plus leptin |
Primary outcome
Hormone levels change from baseline.
Time frame: Change from baseline after 4 days of intervention.
Original study looking at gonadotropin pulsitility, TSH secretion and thyroid function, and cortisol secretion. Present study looking at gut-hormone secretion.
1 secondary outcome
Levels of inflammatory cytokines change from baseline.
Time frame: Change from baseline after 4 days of intervention.
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 10 Dec 2010.
- Results publication: PubMed 16076944Canavan B, Salem RO, Schurgin S, Koutkia P, Lipinska I, Laposata M, Grinspoon S. Effects of physiological leptin administration on markers of inflammation, platelet activation, and platelet aggregation during caloric deprivation. J Clin Endocrinol Metab. 2005 Oct;90(10):5779-85. doi: 10.1210/jc.2005-0780. Epub 2005 Aug 2.
- Results publication: PubMed 15531489Schurgin S, Canavan B, Koutkia P, Depaoli AM, Grinspoon S. Endocrine and metabolic effects of physiologic r-metHuLeptin administration during acute caloric deprivation in normal-weight women. J Clin Endocrinol Metab. 2004 Nov;89(11):5402-9. doi: 10.1210/jc.2004-1102.
- Results publication: PubMed 15972272Koutkia P, Schurgin S, Berry J, Breu J, Lee BS, Klibanski A, Grinspoon S. Reciprocal changes in endogenous ghrelin and growth hormone during fasting in healthy women. Am J Physiol Endocrinol Metab. 2005 Nov;289(5):E814-22. doi: 10.1152/ajpendo.00093.2005. Epub 2005 Jun 21.
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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.
Steven K Grinspoon, MD principal investigator
Massachusetts General Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Leptin administration and Fasting in people with Healthy, run by Massachusetts General Hospital at 2 sites 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 6 inclusion and 6 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 10 Dec 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. Some participants in this study may receive a placebo. 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.
What does the primary outcome measure?
Hormone levels change from baseline. (time frame: Change from baseline after 4 days of intervention.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01257841, which also lists 3 linked publications.
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 10 Dec 2010.