Trial Outcomes & Findings for Mechanisms of Obesity and Its Metabolic Complications in Youth (NCT NCT03454828)
NCT ID: NCT03454828
Last Updated: 2025-10-09
Results Overview
Starting at 08:00, we began a 10-h, primed, continuous, peripheral venous infusion of 99% sodium \[d3\]-acetate with a priming dose of 200 μg · kg-1 · min-1 for 4 min and a continuous infusion rate of 59.5 μg · kg-1 · min-1 for 10 h. After 180 min from the start of the infusion, subjects received 20 g of lactulose per os, dissolved in 30 mL of water.
COMPLETED
NA
38 participants
Pre lactulose (average values at 2, 2.5, 3 hours) and Post lactulose (average of values at 7, 8, 9 and 10 hours)
2025-10-09
Participant Flow
Children and adolescents between 15 and 25 years of age.
Participant milestones
| Measure |
Youth With Obesity
Obese adolescents with a body mass index (BMI) \>95th percentile.
|
Lean Youth
Lean adolescents with a body mass index (BMI) \<85th percentile.
|
|---|---|---|
|
Overall Study
STARTED
|
19
|
19
|
|
Overall Study
COMPLETED
|
19
|
19
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Mechanisms of Obesity and Its Metabolic Complications in Youth
Baseline characteristics by cohort
| Measure |
Youth With Obesity
n=19 Participants
Obese adolescents with a body mass index (BMI) \>95th percentile.
|
Lean Youth
n=19 Participants
Lean adolescents with a body mass index (BMI) \<85th percentile.
|
Total
n=38 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
12 Participants
n=93 Participants
|
16 Participants
n=4 Participants
|
28 Participants
n=27 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
7 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
10 Participants
n=27 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=93 Participants
|
9 Participants
n=4 Participants
|
20 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=93 Participants
|
10 Participants
n=4 Participants
|
18 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
6 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
14 Participants
n=93 Participants
|
18 Participants
n=4 Participants
|
32 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
8 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
8 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=93 Participants
|
17 Participants
n=4 Participants
|
23 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
5 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
7 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Rate of appearance of acetate
|
7.40 μmol · kg-1 · min-1
STANDARD_DEVIATION 4.44 • n=93 Participants
|
7.69 μmol · kg-1 · min-1
STANDARD_DEVIATION 7.541 • n=4 Participants
|
7.55 μmol · kg-1 · min-1
STANDARD_DEVIATION 6.097 • n=27 Participants
|
PRIMARY outcome
Timeframe: Pre lactulose (average values at 2, 2.5, 3 hours) and Post lactulose (average of values at 7, 8, 9 and 10 hours)Starting at 08:00, we began a 10-h, primed, continuous, peripheral venous infusion of 99% sodium \[d3\]-acetate with a priming dose of 200 μg · kg-1 · min-1 for 4 min and a continuous infusion rate of 59.5 μg · kg-1 · min-1 for 10 h. After 180 min from the start of the infusion, subjects received 20 g of lactulose per os, dissolved in 30 mL of water.
Outcome measures
| Measure |
Youth With Obesity
n=19 Participants
Obese adolescents with a body mass index (BMI) \>95th percentile.
|
Lean Youth
n=19 Participants
Lean adolescents with a body mass index (BMI) \<85th percentile.
|
|---|---|---|
|
Rate of Appearance of Acetate
Pre-lactulose
|
7.40 umol/kg/min
Standard Error 1.73
|
7.69 umol/kg/min
Standard Error 1.02
|
|
Rate of Appearance of Acetate
Post-lactulose
|
9.29 umol/kg/min
Standard Error 1.44
|
14.7 umol/kg/min
Standard Error 2.33
|
PRIMARY outcome
Timeframe: Pre lactulose (average values at 2, 2.5, 3 hours) and Post lactulose (average of values at 7, 8, 9 and 10 hours)The percent of hepatic de novo lipogenesis (DNL) refers to the proportion of fatty acids in the liver that are derived from a de novo synthesis pathway, rather than from dietary sources.
Outcome measures
| Measure |
Youth With Obesity
n=6 Participants
Obese adolescents with a body mass index (BMI) \>95th percentile.
|
Lean Youth
n=5 Participants
Lean adolescents with a body mass index (BMI) \<85th percentile.
|
|---|---|---|
|
Percent of Hepatic de Novo Lipogenesis.
Pre Lactulose
|
1.96 Percentage
Standard Error 0.159
|
2.53 Percentage
Standard Error 0.364
|
|
Percent of Hepatic de Novo Lipogenesis.
Post Lactulose
|
1.97 Percentage
Standard Error 0.192
|
3.38 Percentage
Standard Error 0.62
|
PRIMARY outcome
Timeframe: Pre lactulose (average values at 2, 2.5, 3 hours) and Post lactulose (average of values at 7, 8, 9 and 10 hours)The changes in rate of appearance of acetate (RaAcetate) are measured averaging the basal RaAcetate 9 timepoints (2 and 3 hours) and the post-lactulose RaAcetate (timepoints 7, 8, 9 and 10 hours).
Outcome measures
| Measure |
Youth With Obesity
n=4 Participants
Obese adolescents with a body mass index (BMI) \>95th percentile.
|
Lean Youth
n=4 Participants
Lean adolescents with a body mass index (BMI) \<85th percentile.
|
|---|---|---|
|
Change in the Rate of Appearance of Acetate
Pre Diet
|
-2.34 micromol/Kg/minute
Standard Deviation 6.57
|
1.63 micromol/Kg/minute
Standard Deviation 1.75
|
|
Change in the Rate of Appearance of Acetate
Post Diet
|
-1.59 micromol/Kg/minute
Standard Deviation 7.55
|
-0.96 micromol/Kg/minute
Standard Deviation 6.76
|
Adverse Events
Youth With Obesity or Overweight
Youth Without Obesity
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Nicola Santoro
Yale University School of Medicine: Pediatrics Endocrinology
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place