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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
University of Aarhus
About
Eligibility
Locations
Outcomes
Full info

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

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Obese

Exclusion Criteria:

  • Diabetes
  • Other severe disease

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    March 2, 2009
    Last Updated
    March 2, 2009
    Sponsor
    University of Aarhus
    Collaborators
    Aarhus University Hospital
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    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

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    The Effect of Weight Loss on Serum Mannose-Binding Lectin(MBL) Levels

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