NCT00854412

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable obesity

Timeline
Completed

Started Mar 1995

Shorter than P25 for not_applicable obesity

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 1995

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 1995

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 1995

Completed
13.8 years until next milestone

First Submitted

Initial submission to the registry

March 2, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 3, 2009

Completed
Last Updated

March 3, 2009

Status Verified

March 1, 2009

Enrollment Period

3 months

First QC Date

March 2, 2009

Last Update Submit

March 2, 2009

Conditions

ObesityWeight Loss

Keywords

ObesityWeight lossVery low-calorie dietMannose-binding lectinInsulin resistance

Interventions

Weight lossOTHER

Very low-calorie diet (VLCD) of 800 kcal/day for 8 weeks

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Obese

You may not qualify if:

  • Diabetes
  • Other severe disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

ObesityWeight LossInsulin Resistance

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBody Weight ChangesHyperinsulinismGlucose Metabolism DisordersMetabolic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 2, 2009

First Posted

March 3, 2009

Study Start

March 1, 1995

Primary Completion

June 1, 1995

Study Completion

June 1, 1995

Last Updated

March 3, 2009

Record last verified: 2009-03