Fetuin-A Phosphorylation Status in Insulin Resistance and Metabolic Syndrome

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.

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Key information

Conditions

Obesity Body Weight Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Metabolic Syndrome Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

30 year–65 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Auburn University

Auburn, Alabama, 36849, United States

About this study

There are several objectives of this study: (1) Quantitate phosphorylated fetuin-A levels and the daily variation in these levels in individuals with insulin resistance and metabolic syndrome; (2) Investigate the short-term responses of fetuin-A phosphorylation and changes in insulin resistance that occur with a single session of aerobic exercise; (3) Characterize and 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, and; (4) Investigate the influence of weight loss on the short-term responses of fetuin-A phosphorylation and changes in insulin resistance that occur with a single session of aerobic exercise. Our hypothesis is that phosphofetuin-A levels are tightly correlated with insulin resistance and that lifestyle modifications will improve insulin sensitivity and decrease phosphorylated fetuin-A levels.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

30 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

Exclusion criteria

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

Treatment and study plan

Weight loss

Other

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

Primary outcomes

Total plasma fetuin-A and phosphorylated fetuin-A

Time frame: 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.

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

Sponsors and collaborators

Lead sponsor

Auburn University

Other

Registry information

Official study title

Alterations in Phosphorylated Fetuin-A, a Novel Regulator of Insulin Action in Insulin Resistance and Metabolic Syndrome: Effects of Lifestyle Modification

Important dates

Study start: 2007
Primary completion: 2015
Study completion: 2015
First posted: Mar 27, 2018
Registry last updated: Mar 27, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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