The Effect of Weight Loss on Serum Mannose-Binding Lectin(MBL) Levels (WLMBL)
Primary Purpose
Obesity, Weight Loss
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Weight loss
Sponsored by
About this trial
This is an interventional prevention trial for Obesity focused on measuring Obesity, Weight loss, Very low-calorie diet, Mannose-binding lectin, Insulin resistance
Eligibility Criteria
Inclusion Criteria:
- Obese
Exclusion Criteria:
- Diabetes
- Other severe disease
Sites / Locations
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00854412
First Posted
March 2, 2009
Last Updated
March 2, 2009
Sponsor
University of Aarhus
Collaborators
Aarhus University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT00854412
Brief Title
The Effect of Weight Loss on Serum Mannose-Binding Lectin(MBL) Levels
Acronym
WLMBL
Official Title
The Effect of Weight Loss on Serum Mannose-Binding Lectin (MBL) Levels
Study Type
Interventional
2. Study Status
Record Verification Date
March 2009
Overall Recruitment Status
Completed
Study Start Date
March 1995 (undefined)
Primary Completion Date
June 1995 (Actual)
Study Completion Date
June 1995 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University of Aarhus
Collaborators
Aarhus University Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Weight Loss
Keywords
Obesity, Weight loss, Very low-calorie diet, Mannose-binding lectin, Insulin resistance
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
36 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Other
Intervention Name(s)
Weight loss
Intervention Description
Very low-calorie diet (VLCD) of 800 kcal/day for 8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Obese
Exclusion Criteria:
Diabetes
Other severe disease
12. IPD Sharing Statement
Learn more about this trial
The Effect of Weight Loss on Serum Mannose-Binding Lectin(MBL) Levels
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