ObesityNCT01780870
Weight Loss Study-Mechanism Underlying the Improvement of Insulin Resistance in Response to Weight Loss
A study testing Weight loss group (Full meal replacement products) in people with Obesity and Weight Loss, run by Beth Israel Deaconess Medical Center at 1 site in United States.
Trial summary
The main purpose of this study is to assess factors mediating the changes in insulin sensitivity and glucose tolerance before and after 10 lbs ± or 2% weight loss reduction as well as 2, 3, 6, 12, and 24 months after initiation of a low calorie diet. The investigators will also study the following: 1. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Weight Loss
- What is being tested?
- Weight loss group (Full meal replacement products)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2012to Jan 2017
- Phase
- Interventional
- 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 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Adult men and women, age 18-50
- English speaking
- Body mass index (pre weight loss) ≥30 kg/m2 but <40 kg/m2
- Willing to enroll in a low calorie full meal replacement weight loss program
- Willing and able to take part in a multi year study involving visits
- Adult men and women, age 18-50
Show all 9Show fewer
- English speaking
- Body mass index (pre weight loss) ≥30 kg/m2 but <40 kg/m2
- Willing and able to take part in a multi year study involving visits
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02115
About this study
The main purpose of this study is to assess factors mediating the changes in insulin sensitivity and glucose tolerance before and after 10 lbs ± or 2% weight loss reduction as well as 2, 3, 6, 12, and 24 months after initiation of a low calorie diet.
The investigators will also study the following:
- The impact of diet induced weight loss on hormones/adipokine levels
- The impact of diet induced weight loss on leptin tolerance
- Conditions
- Obesity, Weight Loss
- Being tested
- Weight loss group (Full meal replacement products)
- Keywords
- Overweight, Obesity, Obese, Weight loss
- Medical subject headings
- Obesity, Weight Loss, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Weight loss group (Full meal replacement products)Dietary supplement
Also called Full meal replacement products (1280-1320 kcal/day)
In the intervention arm of this non randomized, open label study to assess the effects of weight loss on insulin sensitivity and leptin tolerance subjects will use full meal replacement products (1280-1320kcal/day). Subjects will be on the full meal replacement products only, for the first 12 weeks, between 13 to 19 weeks they will be transitioned to regular food, from 19 weeks and going forward they will be on chronic maintenance phase
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | Obese, otherwise healthy people who are not receiving any nutritional,surgical or behavioral therapy |
| Weight loss group | Active comparator | Full Meal replacement Protocol Receives: Dietary Supplement: Weight loss group (Full meal replacement products) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Primary Outcome Will be the Leptin Levels at Baseline and 8 Weeks
The secondary outcome was deleted, since it was finally not performed in the study due to problems in enrollment
Measured: 8 weeks
The Primary Outcome Will be Insulin Levels at Baseline and 8 Weeks
The secondary outcome was deleted, since it was finally not performed in the study due to problems in enrollment
Measured: 8 weeks
The Primary Outcome Will be HOMA-IR at Baseline and 8 Weeks
The secondary outcome was deleted, since it was finally not performed in the study due to problems in enrollment
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2013 (estimated)
- Study startSep 2012
- Primary completionJan 2017
- Study completionJan 2017
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.
- More trials run by Beth Israel Deaconess Medical CenterThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beth Israel Deaconess Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christos Mantzoros, Beth Israel Deaconess Medical Center
- Investigators
- Christos Mantzoros, MD, Principal investigator, Beth Israel Deaconess Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01780870
- Sponsor's protocol ID
- 2011P000293
- Status last verified
- May 2017
- First submitted
- 29 Jan 2013
- Last updated
- 7 Aug 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Weight Loss Study-Mechanism Underlying the Improvement of Insulin Resistance in Response to Weight Loss
- ClinicalTrials.gov ID
- NCT01780870
- Acronym / sponsor ID
- 2011P000293
- Conditions
- Obesity, Weight Loss
- Keywords
- Overweight, Obesity, Obese, Weight loss
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Beth Israel Deaconess Medical CenterUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- Jan 2017 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 31 Jan 2013 (estimated)
- Results
- Posted 7 Aug 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main purpose of this study is to assess factors mediating the changes in insulin sensitivity and glucose tolerance before and after 10 lbs ± or 2% weight loss reduction as well as 2, 3, 6, 12, and 24 months after initiation of a low calorie diet.
The investigators will also study the following:
- The impact of diet induced weight loss on hormones/adipokine levels
- The impact of diet induced weight loss on leptin tolerance
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –Obese, otherwise healthy people who are not receiving any nutritional,surgical or behavioral therapy |
| Weight loss group | Active comparator | Dietary Supplement: Weight loss group (Full meal replacement products)Full Meal replacement Protocol |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Adult men and women, age 18-50
- English speaking
- Body mass index (pre weight loss) ≥30 kg/m2 but <40 kg/m2
- Willing to enroll in a low calorie full meal replacement weight loss program
- Willing and able to take part in a multi year study involving visits
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Weight loss group (Full meal replacement products)Also: Full meal replacement products (1280-1320 kcal/day)In the intervention arm of this non randomized, open label study to assess the effects of weight loss on insulin sensitivity and leptin tolerance subjects will use full meal replacement products (1280-1320kcal/day). Subjects will be on the full meal replacement products only, for the first 12 weeks, between 13 to 19 weeks they will be transitioned to regular food, from 19 weeks and going forward they will be on chronic maintenance phase | Dietary supplement | Weight loss group |
Primary outcome
The Primary Outcome Will be the Leptin Levels at Baseline and 8 Weeks
Time frame: 8 weeks
The secondary outcome was deleted, since it was finally not performed in the study due to problems in enrollment
The Primary Outcome Will be Insulin Levels at Baseline and 8 Weeks
Time frame: 8 weeks
The secondary outcome was deleted, since it was finally not performed in the study due to problems in enrollment
The Primary Outcome Will be HOMA-IR at Baseline and 8 Weeks
Time frame: 8 weeks
The secondary outcome was deleted, since it was finally not performed in the study due to problems in enrollment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Christos Mantzoros, MD principal investigator
Beth Israel Deaconess Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Weight loss group (Full meal replacement products) in people with Obesity and Weight Loss, run by Beth Israel Deaconess 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 9 inclusion and 0 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 7 Aug 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 7 Aug 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?
The Primary Outcome Will be the Leptin Levels at Baseline and 8 Weeks (time frame: 8 weeks). 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 7 Aug 2017.