Fetuin-A Phosphorylation Status in Insulin Resistance and Metabolic Syndrome

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03478046
• Other study ID #: 07-210-MR0710
• Status: Completed
• Phase: N/A
• First received: March 19, 2018
• Last updated: March 23, 2018
• Start date: October 10, 2007
• Est. completion date: May 31, 2015

Study information

• Verified date: March 2018
• Source: Auburn University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: May 31, 2015
• Est. primary completion date: May 31, 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 30 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Insulin Resistance
• Metabolic Syndrome
• Metabolic Syndrome X
• Obesity
• Syndrome

Intervention

Other:
• Weight loss
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

Locations

Country	Name	City	State
United States	Auburn University	Auburn	Alabama

Sponsors (1)

Lead Sponsor	Collaborator
Auburn University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.