An interventional study of Fructose + Glucose Beverage in Adolescent Obesity, sponsored by The Rogosin Institute. Terminated at 1 site in United States. Open to participants aged 12 Years to 21 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-03-15.
Sponsored by The Rogosin Institute · Not applicable, Interventional, and Screening
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Among 558 studies in Pediatric Obesity with a site in United States — 75 open to participants now, 110 under way, 3 of them phase 3. Pediatric Obesity · United States.
Among the 558 studies in Pediatric Obesity with a site in United States, this one is the 439th largest by enrollment of the 475 interventional ones that give a count, is one of 44 that started in 2018, is one of 423 with no phase, and was the 268th registered.
1,131 studies on the registry are indexed under Pediatric Obesity; 185 are open to participants now.
Browse Pediatric Obesity studies →75 of the 558 studies in Pediatric Obesity with a site in United States are open now. Recruiting first, the newest first:
Stanford University · Sites in United States
Ages 10–15
Children's Hospital Los Angeles · Sites in United States
Ages 12–18
Virginia Commonwealth University · Sites in United States
Ages 12–15 · Healthy volunteers
University of Michigan · Sites in United States
Ages 4 mo+ · Healthy volunteers
Russell McCulloh, MD · Sites in United States
Ages 12–17
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 122 Pediatric Obesity studies recruiting now, 18 (15%) set no upper age limit and 102 (84%) stop at 75 or younger; 112 take children under 18; 68 take healthy volunteers.
This study: 12 Years to 21 Years · all sexes · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
558 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 13 · Phase 2 27 · Phase 3 10 · Phase 4 11
First in 1998; this study’s year is marked. 44 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 12 is below the median of 100 across 872 interventional studies indexed under Pediatric Obesity.
Median enrollment 95 across the 475 interventional studies, 120 across the 81 observational. Of the 418 that completed or were terminated, 116 (28%) have results posted.
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7 of 558 have an industry lead sponsor. The 10 most frequent:
The Rogosin Institute is the lead sponsor of 24 studies on the registry; 3 are open to participants now.
The Rogosin Institute has 1 study filed under Pediatric Obesity — fewer than ten, so there is no comparison to draw.
39 of the studies in Pediatric Obesity with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT04974554Medical University of South CarolinaFIT Families Multicomponent Obesity Intervention for African American Adolescents | 2026-11-30 |
| NCT06810557Temple UniversityBrief Behavioral Sleep Intervention for Obesity Prevention in Primary Care | 2026-11-30 |
| NCT04971044Vanderbilt University Medical CenterCompetency Based Approaches for Community Health 2 | 2026-12 |
| NCT05067621Yale UniversitySemaglutide Effects in Obese Youth With Prediabetes/New Onset Type 2 Diabetes and Metabolic Dysfunction-Associated Steatotic Liver Disease | 2026-12 |
| NCT04128995Children's Hospital Medical Center, CincinnatiSurgical or Medical Treatment | 2026-12 |
Add all 39 to your calendar (.ics) → With an account.
Among the 558 studies in Pediatric Obesity with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Group 1: \<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%
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Intervention: Oral challenge of Fructose+Glucose Beverage 1:1, 3g/kg
Other: Fructose + Glucose Beverage
Intervention: Oral challenge of Fructose+Glucose Beverage 1:1, 3g/kg
Other: Fructose + Glucose Beverage
The intervention is an oral sugar challenge with blood sampling over three hours.
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
Time frame: Three hours
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. 2) To correlate these markers with the increase in VLDL TG %16:0.
Time frame: Three hours
Plan to share: No
No publications or documents are linked to this record.
Ran from Aug 2018 to primary completion in Jun 2019, 9 months.
How these figures are worked out, and which studies are left out of them.
This study is terminated, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.
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The Rogosin Institute