Adolescent ObesityNCT03567837
Fructose-induced Hepatic De Novo Lipogenesis in Adolescents With Obesity
A study testing Fructose + Glucose Beverage in people with Adolescent Obesity, run by The Rogosin Institute at 1 site in United States.
Trial summary
In the U.S., dietary fructose has increased in parallel with the increase in obesity and may promote the development of diabetes and other chronic diseases. The largest source of dietary fructose is sweetened beverages that are consumed by adolescents more than any other age group. Read more about this study
- Who is it for?
- Ages 12 to 21 yearsHealthy volunteers can take part
- Conditions the study is for
- Adolescent Obesity
- What is being tested?
- Fructose + Glucose Beverage
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Aug 2018to 4 Jun 2019
- 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 12 to 21 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Age: 12-21 years old.
- BMI percentile >95th and <140th percentile of the 95th, maximum weight 110 kg.
- Group 1: HbA1C <5.7% and no history of fasting hyperglycemia (glucose greater or equal to100 mg/dL and/or HbA1C greater or equal to 5.7%), sustained hypertension (>95th percentile) or abnormal lipids (LDL cholesterol <130 mg/dL, TG <130 mg/dL, HDL-C >40 mg/dL).
- Group 2: HbA1C greater or equal to 5.7 to 6.49%
- Pubertal or post- pubertal stage (pre-pubertal excluded).
- Willing and able to stop fish oil, fiber supplement, other non-prescribed vitamins/supplements for 1 week prior to study visit.
- Willing to not drink alcohol for at least 48 hours before the study visit.
- Willing to refrain from vigorous exercise the day before the study visit.
Who cannot join
- Diabetes (fasting blood glucose greater or equal to126 mg/dL, and/or HbA1C >6.5% and/or history of a 2 hour oral glucose tolerance test (OGTT) >200 mg/dL).
- Triglycerides >500 mg/dL, LDL cholesterol >160 mg/dL.
- Medications affecting lipid or glucose metabolism, including hormonal contraceptives.
- Liver disease or intestinal dysfunction. Serum glutamate oxaloacetate and/or serum glutamate pyruvate < 2x upper limit normal is permitted if there is no diagnosis of liver disease by a gastroenterologist.
- Weight loss >10% in past 6 months.
- Cigarette smoking.
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- Alcohol or drug abuse.
- Systemic illness, including polycystic ovary disease and acute infections within two weeks of study visits.
- Anemia.
- Pregnancy or breast feeding.
- Psychiatric illness.
- Extreme diet or level of physical activity.
- Fructose intolerance.
- Implanted electronic devices (bioimpedance measurement).
- Any other condition, which in the opinion of the principal investigator, should prohibit participation in the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Weill Cornell Medicial College
New York, New York, 10065
About this study
In the U.S., dietary fructose has increased in parallel with the increase in obesity and may promote the development of diabetes and other chronic diseases. The largest source of dietary fructose is sweetened beverages that are consumed by adolescents more than any other age group.
This protocol will compare the rates of hepatic de novo lipogenesis (DNL), a process in the liver that changes sugar into fat, in two groups of obese adolescents - one with prediabetes and the other, metabolically healthy. Blood will be sampled before and hourly for 3 hours after the consumption of a fructose-containing beverage. We hypothesize that the pre-diabetic group will show greater DNL in response to fructose. This would support other evidence that increased fructose-induced hepatic DNL is an early mechanism linking dietary sugar to the adverse metabolic sequelae of obesity, including diabetes, fatty liver, dyslipidemia and coronary disease.
Read the detailed description
Hypothesis: Hepatic DNL in response to the ingestion of fructose:glucose 1:1 is significantly greater in adolescents with obesity and prediabetes compared to adolescents with obesity who are metabolically healthy.
Thirty obese adolescents, ages 12-21 years, will be recruited to each of two groups: 1) prediabetes (n=15) and 2) metabolically healthy (n=15). An attempt will be made to achieve similar age, sex and BMI distributions in the two groups.
Visit 1- Screening: Eligible subjects will be enrolled after Informed consent/assent are obtained by a physician investigator. The medical history will be reviewed and a physical exam performed, including an assessment of pubertal status. Blood will be sampled after at least a 12 hour fast (except water) for complete blood count, serum glutamate pyruvate, glucose, HbA1C, and lipid panel, if not previously documented in the medical record within three months of the screening visit. These tests may be done without fasting, but if the glucose or lipid results are not normal, these two tests must be repeated after fasting.
Visit 2 - Sugar Challenge Test with Blood Sampling: Within three months of the screening visit, eligible participants will return after at least a 12 hour fast (except water). General health, family history and recent diet will be reviewed. The height, weight, waist circumference at the umbilicus, and blood pressure will be recorded. A urine sample will be obtained for microalbuminuria. After placement of an intravenous catheter and withdrawal of the baseline blood samples, participants will drink a sweet beverage prepared by a dietician (fructose:glucose 1:1, 3g/kg, in water). Blood sampling will continue every hour for three hours( ~12 mL per time point).
Percent body fat will be measured by bioimpedance. The percent body fat will be calculated by computer software with prediction equations validated in the pediatric and adult age ranges.
Plasma samples will be obtained at 4 time points (0, 1, 2 and 3 hours), the fatty acid composition of plasma very low density lipoprotein triglyceride (VLDL TG), including %palmitate (16:0), will be measured. A lipid panel and VLDL triglycerides and apolipoprotein B levels will also be measured at each time point. Other assays to be performed include insulin and and glucose, HbA1C and high sensitivity C reactive protein (hsCRP, a marker of inflammation). The urine sample will be assayed for microalbuminuria (albumin/creatinine >30 mg/g).
An interim analysis of the primary endpoint (increase in VLDL TG %16:0) will be performed in the first three subjects of each group to determine whether the dose of sugar and sampling duration of 3 hours are sufficient to produce a measurable increase in VLDL TG %16:0.
- Conditions
- Adolescent Obesity
- Being tested
- Fructose + Glucose Beverage
- Medical subject headings
- Pediatric Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fructose + Glucose BeverageOther
The intervention is an oral sugar challenge with blood sampling over three hours.
| Study group | Role | What they receive |
|---|---|---|
| Obese Metabolically Healthy | Active comparator | Intervention: Oral challenge of Fructose+Glucose Beverage 1:1, 3g/kg Receives: Other: Fructose + Glucose Beverage |
| Obese Pre-diabetes | Experimental | Intervention: Oral challenge of Fructose+Glucose Beverage 1:1, 3g/kg Receives: Other: Fructose + Glucose Beverage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Increase in VLDL TG palmitate
In the 2 study groups: a comparison of the increase in VLDL TG palmitate over 3 hours after ingestion of a beverage made with fructose and glucose.
after an oral challenge of fructose+glucose
Measured: Three hours
Secondary outcomes (1)
Correlation of the increase in VLDL TG palmitate and markers of carbohydrate and fatty acid metabolism
In the two study groups: a comparison of other markers of carbohydrate and fatty acid metabolism (i.e. VLDL and total TG, cholesterol, apolipoprotein B, insulin, and glucose) before and after the oral sugar challenge.
- To correlate these markers with the increase in VLDL TG %16:0.
Measured: Three hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2018
- Study start13 Aug 2018
- Primary completion4 Jun 2019
- Study completion4 Jun 2019
Why it stopped: It was stopped due to the inability to recruit during the Covid epidemic.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adolescent ObesityStudies of the same condition, open and under way.
- 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
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Rogosin Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lisa Hudgins, MD, Principal investigator, The Rogosin Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03567837
- Sponsor's protocol ID
- 180401921
- Status last verified
- Mar 2024
- First submitted
- 11 Jun 2018
- Last updated
- 15 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fructose-induced Hepatic De Novo Lipogenesis in Adolescents With Obesity
- ClinicalTrials.gov ID
- NCT03567837
- Acronym / sponsor ID
- 180401921
- Conditions
- Adolescent Obesity
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: It was stopped due to the inability to recruit during the Covid epidemic.
- Enrolment
- 12 participants (actual)
- Lead sponsor
- The Rogosin InstituteUniversity, hospital or other
- Collaborators
- Weill Medical College of Cornell University, University of Missouri-Columbia
- Study start
- 13 Aug 2018 (actual)
- Primary completion
- 4 Jun 2019 (actual)
- Study completion
- 4 Jun 2019 (actual)
- First posted
- 26 Jun 2018 (actual)
- 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.
In the U.S., dietary fructose has increased in parallel with the increase in obesity and may promote the development of diabetes and other chronic diseases. The largest source of dietary fructose is sweetened beverages that are consumed by adolescents more than any other age group.
This protocol will compare the rates of hepatic de novo lipogenesis (DNL), a process in the liver that changes sugar into fat, in two groups of obese adolescents - one with prediabetes and the other, metabolically healthy. Blood will be sampled before and hourly for 3 hours after the consumption of a fructose-containing beverage. We hypothesize that the pre-diabetic group will show greater DNL in response to fructose. This would support other evidence that increased fructose-induced hepatic DNL is an early mechanism linking dietary sugar to the adverse metabolic sequelae of obesity, including diabetes, fatty liver, dyslipidemia and coronary disease.
Detailed description
Hypothesis: Hepatic DNL in response to the ingestion of fructose:glucose 1:1 is significantly greater in adolescents with obesity and prediabetes compared to adolescents with obesity who are metabolically healthy.
Thirty obese adolescents, ages 12-21 years, will be recruited to each of two groups: 1) prediabetes (n=15) and 2) metabolically healthy (n=15). An attempt will be made to achieve similar age, sex and BMI distributions in the two groups.
Visit 1- Screening: Eligible subjects will be enrolled after Informed consent/assent are obtained by a physician investigator. The medical history will be reviewed and a physical exam performed, including an assessment of pubertal status. Blood will be sampled after at least a 12 hour fast (except water) for complete blood count, serum glutamate pyruvate, glucose, HbA1C, and lipid panel, if not previously documented in the medical record within three months of the screening visit. These tests may be done without fasting, but if the glucose or lipid results are not normal, these two tests must be repeated after fasting.
Visit 2 - Sugar Challenge Test with Blood Sampling: Within three months of the screening visit, eligible participants will return after at least a 12 hour fast (except water). General health, family history and recent diet will be reviewed. The height, weight, waist circumference at the umbilicus, and blood pressure will be recorded. A urine sample will be obtained for microalbuminuria. After placement of an intravenous catheter and withdrawal of the baseline blood samples, participants will drink a sweet beverage prepared by a dietician (fructose:glucose 1:1, 3g/kg, in water). Blood sampling will continue every hour for three hours( ~12 mL per time point).
Percent body fat will be measured by bioimpedance. The percent body fat will be calculated by computer software with prediction equations validated in the pediatric and adult age ranges.
Plasma samples will be obtained at 4 time points (0, 1, 2 and 3 hours), the fatty acid composition of plasma very low density lipoprotein triglyceride (VLDL TG), including %palmitate (16:0), will be measured. A lipid panel and VLDL triglycerides and apolipoprotein B levels will also be measured at each time point. Other assays to be performed include insulin and and glucose, HbA1C and high sensitivity C reactive protein (hsCRP, a marker of inflammation). The urine sample will be assayed for microalbuminuria (albumin/creatinine >30 mg/g).
An interim analysis of the primary endpoint (increase in VLDL TG %16:0) will be performed in the first three subjects of each group to determine whether the dose of sugar and sampling duration of 3 hours are sufficient to produce a measurable increase in VLDL TG %16:0.
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Obese Metabolically Healthy | Active comparator | Other: Fructose + Glucose BeverageIntervention: Oral challenge of Fructose+Glucose Beverage 1:1, 3g/kg |
| Obese Pre-diabetes | Experimental | Other: Fructose + Glucose BeverageIntervention: Oral challenge of Fructose+Glucose Beverage 1:1, 3g/kg |
Who may qualify
- Ages
- 12 to 21 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (8 listed)
- Age: 12-21 years old.
- BMI percentile >95th and <140th percentile of the 95th, maximum weight 110 kg.
- Group 1: HbA1C <5.7% and no history of fasting hyperglycemia (glucose greater or equal to100 mg/dL and/or HbA1C greater or equal to 5.7%), sustained hypertension (>95th percentile) or abnormal lipids (LDL cholesterol <130 mg/dL, TG <130 mg/dL, HDL-C >40 mg/dL).
- Group 2: HbA1C greater or equal to 5.7 to 6.49%
- Pubertal or post- pubertal stage (pre-pubertal excluded).
Key exclusion criteria (15 listed)
- Diabetes (fasting blood glucose greater or equal to126 mg/dL, and/or HbA1C >6.5% and/or history of a 2 hour oral glucose tolerance test (OGTT) >200 mg/dL).
- Triglycerides >500 mg/dL, LDL cholesterol >160 mg/dL.
- Medications affecting lipid or glucose metabolism, including hormonal contraceptives.
- Liver disease or intestinal dysfunction. Serum glutamate oxaloacetate and/or serum glutamate pyruvate < 2x upper limit normal is permitted if there is no diagnosis of liver disease by a gastroenterologist.
- Weight loss >10% in past 6 months.
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 |
|---|---|---|
| Fructose + Glucose BeverageThe intervention is an oral sugar challenge with blood sampling over three hours. | Other | Obese Metabolically Healthy, Obese Pre-diabetes |
Primary outcome
Increase in VLDL TG palmitate
Time frame: Three hours
In the 2 study groups: a comparison of the increase in VLDL TG palmitate over 3 hours after ingestion of a beverage made with fructose and glucose. after an oral challenge of fructose+glucose
1 secondary outcome
Correlation of the increase in VLDL TG palmitate and markers of carbohydrate and fatty acid metabolism
Time frame: Three hours
Results and safety
The study was stopped early (reason given: It was stopped due to the inability to recruit during the Covid epidemic.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2024.
- 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.
Lisa Hudgins, MD principal investigator
The Rogosin Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fructose + Glucose Beverage in people with Adolescent Obesity, run by The Rogosin Institute 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 8 inclusion and 15 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: stopped early, as of the sponsor's last update on 15 Mar 2024. 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 was stopped early (reason given: It was stopped due to the inability to recruit during the Covid epidemic.). Results are not available in the source record.
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?
Increase in VLDL TG palmitate (time frame: Three 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 15 Mar 2024.