Ghrelin Regulation and Structure: Effect of Thiazolidinedione Therapy on Ghrelin

NCT00843791 | Terminated Results DMC

• 3 other identifiers: eIRB 3941OCTRI #10647R01DK071161
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to learn more about how insulin resistance (inability to process glucose correctly resulting in mildly elevated glucose levels) affects the hormone ghrelin.

Conditions

Obesity; Insulin Resistance

Keywords

obesity

Outcome Measures

Primary Outcomes (1)

• Total and Active Ghrelin Levels

  The primary outcome of this study will be the comparison of ghrelin suppressibility (total and acylated) in response to meals obese subjects before and after 3-months therapy with a thiazolidinedione.

  0 and 3 months

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Treatment with placebo for 3 months before spectroscopy, hyperinsulinemic-euglycemic clamp, control diet, blood sampling.

Drug: placebo

pioglitizone

ACTIVE COMPARATOR

Treatment with pioglitazone for 3 months before hyperinsulinemic-euglycemic clamp, control diet with blood sampling and spectroscopy.

Drug: pioglitazone

Interventions

placebo DRUG

treatment with placebo for 3 months

Placebo

pioglitazone DRUG

treatment with 30mg daily for two weeks then 45mg every day with pioglitazone for three months

Also known as: thiazolidinedione therapy

pioglitizone

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 to 80, weight stable for at least 3 months
• At lifetime maximal body weight and impaired glucose tolerance (ICT) by the World Health ORganization criteria:
• fasting plasma glucose level of 100- 125mg/dL or
• plasma glucose level between 140 to 149mg/dL following a 75gram oral glucose load

You may not qualify if:

• Actively losing weight
• Smokers
• Alcohol consumption \> 2 drinks/day
• Prescription drug use
• Recreational drug use
• Type 2 Diabetes
• Conditions that contraindicate treatment with pioglitazone such as CHF, impaired liver or kidney function or known sensitivity to pioglitazone

Sponsors & Collaborators

• Oregon Health and Science University: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

Oregon Health & Science University

Portland, Oregon, 97239, United States

Location

MeSH Terms

Conditions

Obesity; Insulin Resistance

Interventions

Pioglitazone

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

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

Limitations and Caveats

Early termination due to fund shortage that led to small numbers of subjects enrolled and no measurements of primary outcome.

Results Point of Contact

• Title: Dr. Jonathan Q Purnell
• Organization: OREGON HEALTH & SCIENCE UNIVERSITY

purnellj@ohsu.edu

5034941056

Study Officials

• Jonathan Q. Purnell, M.D.

  Oregon Health and Science University

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prinicipal Investigator

Study Record Dates

• First Submitted: February 12, 2009
• First Posted: February 13, 2009
• Study Start: February 1, 2009
• Primary Completion: May 1, 2011
• Study Completion: May 1, 2011
• Last Updated: January 30, 2023
• Results First Posted: January 30, 2023

Record last verified: 2023-01

Locations

US (1)