NCT03478046

Brief Summary

Fetuin-A has been identified as a novel physiological regulator of insulin action in vitro, in intact cells and in vivo in animals. Previous research has shown that circulating levels of fetuin-A were increased in animal models of insulin resistance and diabetes. Additionally, several human investigation studies demonstrate a correlation of fetuin-A levels with body mass index, insulin resistance, and a fatty liver. Recently, the investigators have elucidated the role of fetuin-A phosphorylation in the regulation of insulin action, demonstrating that phosphorylation is critical for the inhibitory activity of fetuin-A. The objectives of this study are twofold: (1) Quantitate phosphorylated fetuin-A levels in individuals with insulin resistance and metabolic syndrome, and (2) Investigate the effects of lifestyle modifications (acute or chronic exercise and dietary modifications) on fetuin-A phosphorylation and insulin sensitivity.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
42

participants targeted

Target at P25-P50 for not_applicable obesity

Timeline
Completed

Started Oct 2007

Longer than P75 for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 10, 2007

Completed
7.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2015

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

March 19, 2018

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 27, 2018

Completed
Last Updated

March 27, 2018

Status Verified

March 1, 2018

Enrollment Period

7.6 years

First QC Date

March 19, 2018

Last Update Submit

March 23, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • Total plasma fetuin-A and phosphorylated fetuin-A

    Measure total fetuin-A and phosphorylated fetuin-A levels in plasma

    Total fetuin-A and phosphorylated fetuin-A levels will be measured once every 4 weeks until participant achieves a targeted weight-loss goal of 8-10%. It is anticipated that most participants will achieve their weight-loss goal within 6-10 months.

Study Arms (1)

Obese individuals

EXPERIMENTAL

Apparently healthy, weight-stable, obese and physically inactive male volunteers will be recruited. Intervention is an 8 to 10% weight loss induced by chronic exercise training and dietary modification

Other: Weight loss

Interventions

Compare the total and temporal changes in fetuin-A phosphorylation and insulin resistance that occur with an 8 to 10% weight loss induced by chronic exercise training and dietary modification

Obese individuals

Eligibility Criteria

Age30 Years - 65 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • to 65 years of age
  • obese (BMI \> 30 kg⋅m2 or % fat \> 30, and waist girth \> 88 cm)
  • weight stable over the previous 6 months

You may not qualify if:

  • smoker
  • documented cardiovascular or metabolic disease
  • currently taking medication to alter lipid or glucose metabolism
  • practicing regular leisure physical activity over the previous 6 months
  • engaged in strenuous vocational activity over the previous 6 months
  • signs or symptoms of latent heart disease
  • conditions that would preclude treadmill walking

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Auburn University

Auburn, Alabama, 36849, United States

Location

Related Publications (1)

  • Ren G, Bowers RL, Kim T, Mahurin AJ, Grandjean PW, Mathews ST. Serum fetuin-A and Ser312 phosphorylated fetuin-A responses and markers of insulin sensitivity after a single bout of moderate intensity exercise. Physiol Rep. 2021 Mar;9(5):e14773. doi: 10.14814/phy2.14773.

MeSH Terms

Conditions

ObesityMetabolic Syndrome

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsInsulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic Diseases

Study Officials

  • Suresh Mathews, PhD

    Auburn University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

March 19, 2018

First Posted

March 27, 2018

Study Start

October 10, 2007

Primary Completion

May 31, 2015

Study Completion

May 31, 2015

Last Updated

March 27, 2018

Record last verified: 2018-03

Data Sharing

IPD Sharing
Will not share

Locations