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NCT01257841 · ClinicalTrials.gov registry record · NA

Secondary Analysis of Gut Hormones and Inflammatory Cytokines in Fasting Subjects

A NA study, sponsored by Massachusetts General Hospital.

Completed
Registry status
NA
Development phase
20
Enrollment target

NCT01257841: Completed NA study, sponsored by Massachusetts General Hospital.

NCT01257841 is a NA study that has completed, run by Massachusetts General Hospital. The registered enrollment target is 20 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.

View on ClinicalTrials.gov ↗

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The verdict

NCT01257841, a NA study, has completed, sponsored by Massachusetts General Hospital.

COMPLETED
Registry status
NA
Development phase
20 participants
Enrollment target

Study 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. 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.

Primary Outcome

Original study looking at gonadotropin pulsitility, TSH secretion and thyroid function, and cortisol secretion. Present study looking at gut-hormone secretion.

Interventions

  • BEHAVIORAL Fasting
  • DRUG Leptin administration

Trial Details

FieldValue
Enrollment Target 20 participants
Start Date 2002-11
Est. Completion 2003-12
Phase NA
Massachusetts General Hospital

2,032 total trials

What the finished NCT01257841 record still lists

NCT01257841 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).

The record links to 0 conditions, and to 2 interventions - of which Fasting is the first listed.

NCT01257841 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01257841 about?

NCT01257841 is a clinical study titled "Secondary Analysis of Gut Hormones and Inflammatory Cytokines in Fasting Subjects". 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...

What is the current status of trial NCT01257841?

This trial is currently completed. It is a NA study. The enrollment target is 20 participants. The study started on 2002-11. Estimated completion is 2003-12.

What interventions are being tested in trial NCT01257841?

The interventions under investigation include: Fasting (BEHAVIORAL), Leptin administration (DRUG).

Who is sponsoring clinical trial NCT01257841?

This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01257841's enrollment target sits among peer trials

20 1768th of 2000 higher than 140 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT01257841, the US trial registry maintained by the National Library of Medicine. NCT01257841 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.