Mechanisms Underlying Metabolic Syndrome in Obesity

NCT00579813 | Completed Phase 4 Results FDA Drug

• 2 other identifiers: 32677R01DK071277
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this study is to better understand the link between obesity and diabetes or pre-diabetes.

Conditions

Metabolic Syndrome; Insulin Resistance; Prediabetes

Keywords

obesity; inflammation; diabetes

Outcome Measures

Primary Outcomes (4)

• Change in Insulin Sensitivity Using FSIGT

  The frequently sampled intravenous glucose tolerance test (FSIGT) involves the injection of IV glucose and the frequent measurement of glucose and insulin.

  Baseline and 10 weeks

• Effects of Pioglitazone on Changes in BMI

  Body Mass Index (BMI) is measured at baseline, in lean and obese subjects, and after pioglitazone in obese subjects

  Baseline and 10 weeks

• Changes in Muscle Lipid After Pioglitazone

  Muscle lipid following biopsy using oil red-O staining.

  At baseline and 10 weeks

• Changes in Fat Inflammation Following Pioglitazone

  macrophages in fat at baseline, in lean and obese participants, and obese after pioglitazone (in obese)

  Baseline and 10 weeks

Study Arms (2)

1

NO INTERVENTION

Baseline studies (OGTT, DXA, RMR, FSIGT, and biopsies) on normal control subjects. Oral glucose tolerance tests, body composition assessment, resting metabolic rate, insulin sensitivity measurement with the frequently sampled method and Minimal Model. These studies will establish baseline data in lean subjects on adipose tissue gene expression, insulin sensitivity, glucose tolerance, metabolic rate and body composition. There is no intervention.

2

ACTIVE COMPARATOR

Baseline studies (OGTT, DXA, RMR, FSIGT, biopsies), then 10 weeks treatment on Pioglitazone. Baseline tests are repeated at the end of medication treatment. All of the studies described in arm 1 are repeated after treatment. The subjects in this group have impaired glucose tolerance. After the measurement of adipose tissue gene expression, insulin sensitivity, glucose tolerance, metabolic rate and body composition, subjects are treated with pioglitazone, working up to 45 mg/day, for 10 weeks. After this time, adipose tissue gene expression, insulin sensitivity, glucose tolerance, metabolic rate and body composition are repeated.

Drug: Pioglitazone

Interventions

Pioglitazone DRUG

Pioglitazone 30mg for 2 weeks, then Pioglitazone 45mg for 8 weeks.

Also known as: Actos

2

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age
• BMI 28+
• diabetes, impaired glucose tolerance or normal glucose tolerance

You may not qualify if:

• AST \>2x normal
• congestive heart failure
• history of coronary artery disease
• chronic renal insufficiency (creatinine \> 1.4mg/dl)
• use of gemfibrozil, ACE inhibitors, and angiotensin receptor II blockers, or anticoagulants

Sponsors & Collaborators

• Philip Kern: lead
• National Institutes of Health (NIH): collaborator
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (2)

University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States

Location

University of Kentucky

Lexington, Kentucky, 40536, United States

Location

MeSH Terms

Conditions

Metabolic Syndrome; Insulin Resistance; Prediabetic State; Obesity; Inflammation; Diabetes Mellitus

Interventions

Pioglitazone

Condition Hierarchy (Ancestors)

Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pathologic Processes

Intervention Hierarchy (Ancestors)

Thiazolidinediones; Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Robert E. McGehee Jr., Ph.D.
• Organization: University of Arkansas for Medical Sciences

rem@uams.edu

501-603-1998

Study Officials

• Philip Kern, MD

  University of Kentucky

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 20, 2007
• First Posted: December 24, 2007
• Study Start: April 1, 2005
• Primary Completion: January 1, 2009
• Study Completion: January 1, 2011
• Last Updated: June 15, 2017
• Results First Posted: July 12, 2011

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will share

Locations

US (2)