CompletedNot Applicable

Regulation of FGF21 by Nutritional Challenges

United States40 participantsStarted 2009-07

Plain-language summary

The purpose of this study is to examine how acute nutritional challenges affect levels of several proteins involved in metabolism. These proteins will be measured in blood and fat tissue. This study will have several aims. One aim is to examine the effect of 72 hours of fasting on fibroblast growth factor-21 (FGF-21) levels. Participants will spend 3 days and nights in the Clinical Research Center at the Beth Israel Deaconess Medical Center in Boston, MA. Daily blood samples will be taken. Two fat samples will be taken prior to and at the end of the fast. A subset of participants will also have two MRIs, one prior to and one at the end of the fast. We will study healthy adults and obese adults with liver-biopsy-diagnosed non-alcoholic fatty liver disease (NAFLD). THIS STUDY ARM IS CURRENTLY NOT RECRUITING Another aim is to examine the effect of low-calorie diet on FGF-21 levels. Subjects will follow a hypocaloric diet that will be designed to achieve 3-5% weight loss. We will enroll participants with liver-biopsy-diagnosed non-alcoholic fatty liver disease. Participants will report weekly to the Clinical Research Center at Beth Israel Deaconess Medical Center for weight measurements. Blood will be drawn before and after the weight loss. Participants will also have an MRI before and after the weight loss. THIS ARM IS CURRENTLY NOT RECRUITING Another aim of the study is to examine the effect of acute ingestion of glucose, fructose, and other sugars on serum FGF21 levels. Subjects in this study will be lean volunteers and individuals with metabolic syndrome. THIS ARM IS CURRENTLY RECRUITING

Who can participate

Age range

18 Years – 60 Years

Sex

ALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

72-hour fast in healthy volunteers (Study Arm A): 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…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Fibroblast Growth Factor 21 levels in serum and fat

Timeframe: before and after dietary intervention

Trial details

NCT IDNCT00968747

SponsorBeth Israel Deaconess Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-07-31

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