ObesityWLMBLNCT00854412
The Effect of Weight Loss on Serum Mannose-Binding Lectin(MBL) Levels
A study testing Weight loss in people with Obesity and Weight Loss, run by University of Aarhus.
Trial summary
High levels of mannose-binding lectin (MBL), an activator of a part of the immune system called the complement system, have been associated with increased mortality and risk of early signs of kidney damage in patients with type 2 diabetes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obesity, Weight Loss
- What is being tested?
- Weight loss
- How many people
- 36 participants
- Where
- No sites listed yet
- Study dates
- Mar 1995to Jun 1995
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Obese
Who cannot join
- Diabetes
- Other severe disease
About this study
Official title: The Effect of Weight Loss on Serum Mannose-Binding Lectin (MBL) Levels
High levels of mannose-binding lectin (MBL), an activator of a part of the immune system called the complement system, have been associated with increased mortality and risk of early signs of kidney damage in patients with type 2 diabetes. The effect of weight loss and changes in insulin resistance on MBL levels have been poorly elucidated.
This study includes 36 nondiabetic obese subjects, who will receive a very low- calorie diet (VLCD) of 800 kcal/day for 8 weeks.
Fasting blood samples will be obtained at baseline and after 8 weeks of VLCD and concentrations of MBL, glucose and insulin will be measured. Insulin resistance is assessed using the HOMA-IR method.
- Conditions
- Obesity, Weight Loss
- Being tested
- Weight loss
- Keywords
- Obesity, Weight loss, Very low-calorie diet, Mannose-binding lectin, Insulin resistance
- Medical subject headings
- Obesity, Weight Loss, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Weight lossOther
Very low-calorie diet (VLCD) of 800 kcal/day for 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2009 (estimated)
- Study startMar 1995
- Primary completionJun 1995
- Study completionJun 1995
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 of AarhusThe 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00854412
- Sponsor's protocol ID
- MBL1
- Acronym
- WLMBL
- Status last verified
- Mar 2009
- First submitted
- 2 Mar 2009
- Last updated
- 3 Mar 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Weight Loss on Serum Mannose-Binding Lectin (MBL) Levels
- ClinicalTrials.gov ID
- NCT00854412
- Acronym / sponsor ID
- WLMBL / MBL1
- Conditions
- Obesity, Weight Loss
- Keywords
- Obesity, Weight loss, Very low-calorie diet, Mannose-binding lectin, Insulin resistance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Aarhus University Hospital
- Study start
- Mar 1995
- Primary completion
- Jun 1995 (actual)
- Study completion
- Jun 1995 (actual)
- First posted
- 3 Mar 2009 (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.
High levels of mannose-binding lectin (MBL), an activator of a part of the immune system called the complement system, have been associated with increased mortality and risk of early signs of kidney damage in patients with type 2 diabetes. The effect of weight loss and changes in insulin resistance on MBL levels have been poorly elucidated.
This study includes 36 nondiabetic obese subjects, who will receive a very low- calorie diet (VLCD) of 800 kcal/day for 8 weeks.
Fasting blood samples will be obtained at baseline and after 8 weeks of VLCD and concentrations of MBL, glucose and insulin will be measured. Insulin resistance is assessed using the HOMA-IR method.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Obese
Key exclusion criteria (2 listed)
- Diabetes
- Other severe disease
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 lossVery low-calorie diet (VLCD) of 800 kcal/day for 8 weeks | Other | – |
Primary outcome
Not reported in the source record.
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 Mar 2009.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Weight loss in people with Obesity and Weight Loss, run by University of Aarhus.
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 1 inclusion and 2 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 Mar 2009. Status can change between updates, so confirm with the study contact before making plans.
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.
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 Mar 2009.