ObesityNCT00840307
Changes in Ectopic Fat Following Surgically Induced Weight Loss
An observational study of Obesity and Type 2 Diabetes, run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial summary
This study evaluates how ectopic fat (in the pancreas, heart, liver and skeletal muscle), visceral fat, and subcutaneous fat changes following surgically induced weight loss using gastric banding. The investigators also evaluate whether changes in pancreatic fat content correlate with improvement in beta-cell function. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obesity, Type 2 Diabetes
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2008to Dec 2012
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients already scheduled to undergo gastric banding within 1-2 months. This study does NOT pay for the bariatric surgery, eligible participants must already be scheduled to have the surgery performed by their own physician
Who may be able to join
- Greater than 18 years old
- Fully understanding and willing to undergo study procedures
- Available for follow-up
- Understand and willing to sign informed consent
- Pharmacologic agents with the potential to change ectopic fat content (i.e. pioglitazone) are allowed if the patient has been on a stable dose for at least 3 months and plans to continue the same dose for the duration of the study
Who cannot join
- Contraindication to MRI (i.e. metallic implants, severe claustrophobia, weight above 320lb)
- Contraindication to phlebotomy (i.e. no accessible veins, hemoglobin <10 mg/dL)
- History of pancreatic disease other than diabetes
- Regular use of more than 2 alcoholic drinks per day
- Pregnancy
- Non-English speaking
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas Southwestern
Dallas, Texas, 75390
About this study
Official title: Changes in Ectopic Fat Following Surgically Induced Weight Loss: Does it Explain the Resolution of Diabetes?
This study evaluates how ectopic fat (in the pancreas, heart, liver and skeletal muscle), visceral fat, and subcutaneous fat changes following surgically induced weight loss using gastric banding. The investigators also evaluate whether changes in pancreatic fat content correlate with improvement in beta-cell function.
Read the detailed description
We are looking for volunteers for this study,wich involves 7 visits over a period of 13 months, the first visit taking place about 2 weeks prior to the planned surgery.
Visit 1 - baseline, before starting your pre-operative diet Visit 2 - just before the surgery Visit 3 - around the time your first band inflation occurs Visit 4 - 1 month after the band inflation Visit 5 - 3 months after the first band inflation Visit 6 - 6 months after the first band inflation Visit 7 - 12 months after the first band inflation
At each visit we do the following tests:
- MRS to measure your fat in the liver, pancreas, heart, muscle (leg), subcutaneous fat and visceral fat.
- Frequently sampled intravenous glucose tolerance test - it is a 3.5 hrs test which determines the amount of insulin your body produces and how well your own insulin is being used by the body
- Body measurements (waist, hip circumference), cholesterol panel, liver function tests, HbA1c (to monitor diabetes control), blood pressure, weight.
We also do an oral glucose tolerance test to check for diabetes on 3 occasions: visit 1, visit 5 and at the end, visit 7.
- Conditions
- Obesity, Type 2 Diabetes
- Keywords
- Obesity, Type 2 Diabetes, Gastric Banding
- Medical subject headings
- Obesity, Diabetes Mellitus, Type 2
What is being measured
The primary outcome is the main question the study is designed to answer.
Pancreatic and Liver Triglyceride (Fat) Content
Pancreatic triglyceride (fat) content measured by the magnetic resonance spectroscopy (MRS) technique in volunteers with a wide range of body mass index (BMI).
Measured: months after the first band inflation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2009 (estimated)
- Study startAug 2008
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Responsible party
- Principal investigator, Ildiko Lingvay, University of Texas Southwestern Medical Center
- Investigators
- Ildiko Lingvay, MD, MPH, Principal investigator, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00840307
- Sponsor's protocol ID
- 072008-039
- Other IDs
- NIH Grant: 1K23RR024470-01
- Status last verified
- Nov 2017
- First submitted
- 6 Feb 2009
- Last updated
- 13 Dec 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changes in Ectopic Fat Following Surgically Induced Weight Loss: Does it Explain the Resolution of Diabetes?
- ClinicalTrials.gov ID
- NCT00840307
- Acronym / sponsor ID
- 072008-039
- Conditions
- Obesity, Type 2 Diabetes
- Keywords
- Obesity, Type 2 Diabetes, Gastric Banding
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Study start
- Aug 2008
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 10 Feb 2009 (estimated)
- Results
- Posted 20 Nov 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study evaluates how ectopic fat (in the pancreas, heart, liver and skeletal muscle), visceral fat, and subcutaneous fat changes following surgically induced weight loss using gastric banding. The investigators also evaluate whether changes in pancreatic fat content correlate with improvement in beta-cell function.
Detailed description
We are looking for volunteers for this study,wich involves 7 visits over a period of 13 months, the first visit taking place about 2 weeks prior to the planned surgery.
Visit 1 - baseline, before starting your pre-operative diet Visit 2 - just before the surgery Visit 3 - around the time your first band inflation occurs Visit 4 - 1 month after the band inflation Visit 5 - 3 months after the first band inflation Visit 6 - 6 months after the first band inflation Visit 7 - 12 months after the first band inflation
At each visit we do the following tests:
- MRS to measure your fat in the liver, pancreas, heart, muscle (leg), subcutaneous fat and visceral fat.
- Frequently sampled intravenous glucose tolerance test - it is a 3.5 hrs test which determines the amount of insulin your body produces and how well your own insulin is being used by the body
- Body measurements (waist, hip circumference), cholesterol panel, liver function tests, HbA1c (to monitor diabetes control), blood pressure, weight.
We also do an oral glucose tolerance test to check for diabetes on 3 occasions: visit 1, visit 5 and at the end, visit 7.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients already scheduled to undergo gastric banding within 1-2 months. This study does NOT pay for the bariatric surgery, eligible participants must already be scheduled to have the surgery performed by their own physician
Key inclusion criteria (5 listed)
- Greater than 18 years old
- Fully understanding and willing to undergo study procedures
- Available for follow-up
- Understand and willing to sign informed consent
- Pharmacologic agents with the potential to change ectopic fat content (i.e. pioglitazone) are allowed if the patient has been on a stable dose for at least 3 months and plans to continue the same dose for the duration of the study
Key exclusion criteria (6 listed)
- Contraindication to MRI (i.e. metallic implants, severe claustrophobia, weight above 320lb)
- Contraindication to phlebotomy (i.e. no accessible veins, hemoglobin <10 mg/dL)
- History of pancreatic disease other than diabetes
- Regular use of more than 2 alcoholic drinks per day
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Pancreatic and Liver Triglyceride (Fat) Content
Time frame: months after the first band inflation
Pancreatic triglyceride (fat) content measured by the magnetic resonance spectroscopy (MRS) technique in volunteers with a wide range of body mass index (BMI).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Obesity
Not yet recruiting
Transcutaneous Auricular Vagus Nerve Stimulation Combined With Lifestyle Intervention for Visceral Fat Reduction in Adults With Overweight or Obesity
Overweight, Obesity
Not yet recruitingObservational study
Assessing the Impact of Perceptions of Unpredictability on Objective Measures of Food Consumption and Metabolism
Healthy Volunteer, Obestity
RecruitingPhase 1/2
HS235 Study in Overweight and Obese Participants With Combined Pre and Post-Capillary Pulmonary Hypertension Due to Heart Failure With Preserved Ejection Fraction
Pulmonary Hypertension, Heart Failure With Preserved Ejection Fraction
Not yet recruitingPhase 3
ELEVATE-LIVER: A Study to Test Whether Survodutide Helps Improve Heart Structure and Function in People With Overweight or Obesity and Fatty Liver Disease
Obesity, Metabolic Dysfunction-associated Steatotic Liver Disease
Not yet recruitingObservational study
A Natural History of Genetic and Environmental Predictors of Pubertal Timing Among Youth With Obesity
Obesity
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.
Ildiko Lingvay, MD, MPH principal investigator
University of Texas Southwestern Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity and Type 2 Diabetes, run by University of Texas Southwestern 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 5 inclusion and 6 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 13 Dec 2017. 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?
Yes. Results are posted in the registry (first posted 20 Nov 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Pancreatic and Liver Triglyceride (Fat) Content (time frame: months after the first band inflation). 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 13 Dec 2017.