FastingNCT02884791
FGF21 and Fructose Challenge in Humans
A study testing oral carbohydrate challenge in people with Fasting, run by Beth Israel Deaconess Medical Center at 1 site in United States.
Trial summary
The primary aim of this study is to examine the effect of acute ingestion of fructose on serum FGF21 levels. Subjects in this study will be lean volunteers and individuals with metabolic syndrome. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Fasting
- What is being tested?
- oral carbohydrate challenge
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2016to 30 May 2023
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Men and women ages 18-60
- BMI 19-25 kg/m2; 19-23 for Asian subjects
- Stable weight (variation < 3 kg within 6 months of screening visit)
- Ability to give informed consent
- Ability to follow verbal and written instructions in English
- Use of medically approved form of contraception (monophasic oral contraception, intra uterine device, surgical sterilization or 2 combined barrier methods)
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- Specific exclusion criteria for lean subjects:
- Fasting blood glucose >100; 2 hr OGTT blood glucose >140
- Fasting triglycerides >150
- 3 or more of the following (based on joint scientific statement by Alberti et al, 2009:
- Fasting triglycerides >150 mg/dl (or on treatment for elevated triglycerides)
- HDL cholesterol <40 mg/dl in men or <50 mg/dl in women
- Blood pressure > 130/85 (or antihypertensive treatment in a subject with history of hypertension)
- Fasting BG >100
- Elevated waist circumference ** see below for race and ethnic specifications
- Men Women
- Asian or Central, South or Native American > 90 cm > 80 cm
- Non-Asian, Non-Latino United States > 102 cm > 88 cm
- General Exclusion criteria
- Type 1 or type 2 diabetes mellitus diagnosed according to American Diabetes Association criteria
- Coronary heart disease (history of myocardial infarction, unstable angina pectoris, or congestive heart failure)
- Uncontrolled hypertension (BP > 160/100 mmHg on or off antihypertensive medication)
- Marijuana or intravenous drug use
- Recent weight loss (> 3 kg within 6 months of the screening visit)
- Gastroparesis
- Inflammatory or irritable bowel disease
- Malignancy treated with chemotherapy within the past 3 years
- Depression or psychosis requiring hospitalization
- Renal insufficiency (creatinine clearance < 40 ml/min)
- Transaminases > 2x above the normal range
- Known liver disease
- Pregnancy within 6 months of the screening visit
- Lactation
- Failure to use medically approved contraceptive methods
- History of surgery for the treatment of obesity (gastric banding, gastric bypass, gastric stapling)
- Change in dose of thyroid hormone or antithyroidal medication within 3 months of screening visit
- History of alcohol abuse within the past 5 years
- Fructose intolerance
- Exclusionary medications:
- Oral steroids
- Metformin
- Weight loss medications including nonprescription supplements
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
About this study
Official title: Fibroblast Growth Factor 21 and Fructose Challenge in Humans
The primary aim of this study is to examine the effect of acute ingestion of fructose on serum FGF21 levels. Subjects in this study will be lean volunteers and individuals with metabolic syndrome.
Read the detailed description
Participation in this study involves fasting overnight, drinking a sweet beverage, and several blood draws through an IV line. Each subject may drink up to 10 different sweet beverages, separated by 2 weeks.
- Conditions
- Fasting
- Being tested
- oral carbohydrate challenge
- Keywords
- FGF21, Fibroblast growth factor, fructose
- Medical subject headings
- Fasting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oral carbohydrate challengeDietary supplement
Participants will fast for 8 hours and then drink a beverage containing fructose.
| Study group | Role | What they receive |
|---|---|---|
| Fasting (Healthy) | Experimental | Participation in this study involves fasting overnight, drinking a sweet beverage, and several blood draws through an IV line. Each subject may drink up to10 different sweet beverages, separated by 2 weeks. Receives: Dietary Supplement: oral carbohydrate challenge |
| Fasting (metabolic syndrome) | Experimental | Participation in this study involves fasting overnight, drinking a sweet beverage, and several blood draws through an IV line. Each subject may drink up to10 different sweet beverages, separated by 2 weeks. Receives: Dietary Supplement: oral carbohydrate challenge |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Fibroblast Growth Factor 21 levels in human serum
Measured: 5 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2016 (estimated)
- Study startFeb 2016
- Primary completion30 May 2023
- Study completion30 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FastingStudies of the same condition, open and under way.
- More trials run by Beth Israel Deaconess Medical CenterThe 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
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beth Israel Deaconess Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jody Dushay, Beth Israel Deaconess Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02884791
- Sponsor's protocol ID
- 2015P000381
- Status last verified
- Aug 2023
- First submitted
- 23 Mar 2016
- Last updated
- 14 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fibroblast Growth Factor 21 and Fructose Challenge in Humans
- ClinicalTrials.gov ID
- NCT02884791
- Acronym / sponsor ID
- 2015P000381
- Conditions
- Fasting
- Keywords
- FGF21, Fibroblast growth factor, fructose
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Beth Israel Deaconess Medical CenterUniversity, hospital or other
- Study start
- Feb 2016 (actual)
- Primary completion
- 30 May 2023 (actual)
- Study completion
- 30 May 2023 (actual)
- First posted
- 31 Aug 2016 (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 primary aim of this study is to examine the effect of acute ingestion of fructose on serum FGF21 levels. Subjects in this study will be lean volunteers and individuals with metabolic syndrome.
Detailed description
Participation in this study involves fasting overnight, drinking a sweet beverage, and several blood draws through an IV line. Each subject may drink up to 10 different sweet beverages, separated by 2 weeks.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fasting (Healthy) | Experimental | Dietary Supplement: oral carbohydrate challengeParticipation in this study involves fasting overnight, drinking a sweet beverage, and several blood draws through an IV line. Each subject may drink up to10 different sweet beverages, separated by 2 weeks. |
| Fasting (metabolic syndrome) | Experimental | Dietary Supplement: oral carbohydrate challengeParticipation in this study involves fasting overnight, drinking a sweet beverage, and several blood draws through an IV line. Each subject may drink up to10 different sweet beverages, separated by 2 weeks. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (42 listed)
- Men and women ages 18-60
- BMI 19-25 kg/m2; 19-23 for Asian subjects
- Stable weight (variation < 3 kg within 6 months of screening visit)
- Ability to give informed consent
- Ability to follow verbal and written instructions in English
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| oral carbohydrate challengeParticipants will fast for 8 hours and then drink a beverage containing fructose. | Dietary supplement | Fasting (Healthy), Fasting (metabolic syndrome) |
Primary outcome
Change in Fibroblast Growth Factor 21 levels in human serum
Time frame: 5 hours
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 14 Aug 2023.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing oral carbohydrate challenge in people with Fasting, run by Beth Israel Deaconess Medical Center at 1 site 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 42 inclusion and 0 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 14 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. 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?
Change in Fibroblast Growth Factor 21 levels in human serum (time frame: 5 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Aug 2023.