Trial Outcomes & Findings for Changes in Ectopic Fat Following Surgically Induced Weight Loss (NCT NCT00840307)
NCT ID: NCT00840307
Last Updated: 2017-12-13
Results Overview
Pancreatic triglyceride (fat) content measured by the magnetic resonance spectroscopy (MRS) technique in volunteers with a wide range of body mass index (BMI).
Recruitment status
COMPLETED
Target enrollment
20 participants
Primary outcome timeframe
months after the first band inflation
Results posted on
2017-12-13
Participant Flow
Participant milestones
| Measure |
Patient With Gastric Band
20 patients recruited from bariatric surgery clinic followed-up before surgery and for 12 months after inflation of the gastric band.
|
|---|---|
|
Overall Study
STARTED
|
20
|
|
Overall Study
COMPLETED
|
16
|
|
Overall Study
NOT COMPLETED
|
4
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Changes in Ectopic Fat Following Surgically Induced Weight Loss
Baseline characteristics by cohort
| Measure |
Patient With Gastric Band
n=20 Participants
20 patients recruited from bariatric surgery clinic followed-up before surgery and for 12 months after inflation of the gastric band.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
20 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
49.1 years
STANDARD_DEVIATION 11.0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
20 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: months after the first band inflationPancreatic triglyceride (fat) content measured by the magnetic resonance spectroscopy (MRS) technique in volunteers with a wide range of body mass index (BMI).
Outcome measures
| Measure |
Patient With Gastric Band
n=16 Participants
20 patients recruited from bariatric surgery clinic followed-up before surgery and for 12 months after inflation of the gastric band.
|
|---|---|
|
Pancreatic and Liver Triglyceride (Fat) Content
Pancreatic fat
|
6.44 percent
Interval 1.75 to 25.02
|
|
Pancreatic and Liver Triglyceride (Fat) Content
Liver fat
|
2.08 percent
Interval 1.43 to 3.63
|
Adverse Events
Patient With Gastric Band
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place