ObesitySMELSSNCT02964780
Study on Mechanisms of Changes in Liver Disease and Sex Steroid Metabolism During Weight Loss
An observational study of Obesity, run by University Ghent at 1 site in Belgium.
Trial summary
The main objective of the study is to gain insight in the early dynamics and mechanisms of recovery of liver disease and sex steroid metabolism during weight loss in obese men and women and to investigate whether surgical weight loss has differential effects as compared to weight loss with life style measures. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Obesity
- What is being tested?
- Gastric bypass surgery and Conservative weight loss program
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- How many people
- 90 participants
- Where
- 1 siteBelgium
- Study dates
- 19 Jan 2016to 5 May 2020
- Phase
- Observational
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with obesity class 3 who want to reduce weight
Who may be able to join
- Informed consent obtained
- BMI > 35 kg/m²
Who cannot join
- Primary or secondary hypogonadism due to genetic causes (Kallman syndrome etc.), tumors, infiltrative diseases, infections, pituitary apoplexy, trauma, critical illness, chronic systemic illness or intentional.
- Type 2 Diabetes Mellitus treated with insulin or GLP-1 analogues
- Current or recent use of insulin, corticosteroids, opiates (on a daily basis), growth hormones, androgen- or estrogen analogs, levothyroxine, anti-retroviral drugs or antipsychotics
- Cancer (within < 5 years)
- High-grade malignancies
- Serious co-morbidities such as renal, hepatic of cardiac failure
- Known or suspected abuse of alcohol or narcotics
- Mental incapacity, unwillingness, or language barrier precluding adequate understanding or cooperation.
Trial locations and contacts
1 site in 1 country.
About this study
The main objective of the study is to gain insight in the early dynamics and mechanisms of recovery of liver disease and sex steroid metabolism during weight loss in obese men and women and to investigate whether surgical weight loss has differential effects as compared to weight loss with life style measures. In addition, we want to evaluate the postprandial hypoglycemic reactive syndrome (PPHRS) in these patients using a standard chewable meal.
Secondary objectives are investigating determinants for the changes in sex steroids, liver disease and PPHRS. Possible determinants to be investigated are adipocytokine secretion patterns, body composition, resting metabolism rate, weight loss per se and changes in fat distribution, parameters of fatty acid metabolism, … .
- Conditions
- Obesity
- Being tested
- Gastric bypass surgery, Conservative weight loss program
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gastric bypass surgeryProcedure or surgery
Conservative weight loss programBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Gastric Bypass Surgery | Solid mixed meal tolerance test, MRI, CT, anthropometrics, liver biopsies, fat biopsies, muscle biopsies Receives: Procedure: Gastric bypass surgery | |
| Conservative weight loss | Solid mixed meal tolerance test, MRI, CT, anthropometrics, liver biopsies, fat biopsies, muscle biopsies Receives: Behavioral: Conservative weight loss program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in sex steroids
The change in sex steroids will be compared between the conservative and the gastric bypass group.
Measured: Baseline, 3 weeks, 6 weeks, 6 months, 1 year.
Change from baseline in liver fat
The change in liver steatose will be compared between the conservative and the gastric bypass group
Measured: Baseline, 6 months, 1 year
Correlation in changes in liver fat en changes in sex steroids
Measured: baseline, 6 months, 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2016 (estimated)
- Study start19 Jan 2016
- Primary completion5 May 2020
- Study completion5 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by University GhentThe sponsor's other registered studies.
- 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-control
- Time perspective
- Prospective
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02964780
- Sponsor's protocol ID
- B670201526667
- Acronym
- SMELSS
- Status last verified
- Dec 2021
- First submitted
- 24 Oct 2016
- Last updated
- 3 Dec 2021
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on Mechanisms of Changes in Liver Disease and Sex Steroid Metabolism During Weight Loss
- ClinicalTrials.gov ID
- NCT02964780
- Acronym / sponsor ID
- SMELSS / B670201526667
- Conditions
- Obesity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- University GhentUniversity, hospital or other
- Study start
- 19 Jan 2016 (actual)
- Primary completion
- 5 May 2020 (actual)
- Study completion
- 5 May 2020 (actual)
- First posted
- 16 Nov 2016 (estimated)
- 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.
The main objective of the study is to gain insight in the early dynamics and mechanisms of recovery of liver disease and sex steroid metabolism during weight loss in obese men and women and to investigate whether surgical weight loss has differential effects as compared to weight loss with life style measures. In addition, we want to evaluate the postprandial hypoglycemic reactive syndrome (PPHRS) in these patients using a standard chewable meal.
Secondary objectives are investigating determinants for the changes in sex steroids, liver disease and PPHRS. Possible determinants to be investigated are adipocytokine secretion patterns, body composition, resting metabolism rate, weight loss per se and changes in fat distribution, parameters of fatty acid metabolism, … .
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gastric Bypass Surgery | – | Procedure: Gastric bypass surgerySolid mixed meal tolerance test, MRI, CT, anthropometrics, liver biopsies, fat biopsies, muscle biopsies |
| Conservative weight loss | – | Behavioral: Conservative weight loss programSolid mixed meal tolerance test, MRI, CT, anthropometrics, liver biopsies, fat biopsies, muscle biopsies |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with obesity class 3 who want to reduce weight
Key inclusion criteria (2 listed)
- Informed consent obtained
- BMI > 35 kg/m²
Key exclusion criteria (8 listed)
- Primary or secondary hypogonadism due to genetic causes (Kallman syndrome etc.), tumors, infiltrative diseases, infections, pituitary apoplexy, trauma, critical illness, chronic systemic illness or intentional.
- Type 2 Diabetes Mellitus treated with insulin or GLP-1 analogues
- Current or recent use of insulin, corticosteroids, opiates (on a daily basis), growth hormones, androgen- or estrogen analogs, levothyroxine, anti-retroviral drugs or antipsychotics
- Cancer (within < 5 years)
- High-grade malignancies
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 |
|---|---|---|
| Gastric bypass surgery | Procedure or surgery | Gastric Bypass Surgery |
| Conservative weight loss program | Behavioural | Conservative weight loss |
Primary outcome
Change from baseline in sex steroids
Time frame: Baseline, 3 weeks, 6 weeks, 6 months, 1 year.
The change in sex steroids will be compared between the conservative and the gastric bypass group.
Change from baseline in liver fat
Time frame: Baseline, 6 months, 1 year
The change in liver steatose will be compared between the conservative and the gastric bypass group
Correlation in changes in liver fat en changes in sex steroids
Time frame: baseline, 6 months, 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2021.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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, run by University Ghent at 1 site in Belgium.
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 2 inclusion and 8 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 3 Dec 2021. 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 Belgium. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change from baseline in sex steroids (time frame: Baseline, 3 weeks, 6 weeks, 6 months, 1 year.). The study lists 3 primary outcomes in all. 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 3 Dec 2021.