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NCT00339833 · ClinicalTrials.gov registry record · Phase 4

The Effects of Anti-Inflammatory Treatment on Insulin Resistance in Healthy Volunteers

A Phase 4 study of Diabetes and Type 2 Diabetes, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).

Completed
Registry status
Phase 4
Development phase
54
Enrollment target
1
Study location

NCT00339833 is a Phase 4 study of Diabetes and Type 2 Diabetes that has completed, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). The registered enrollment target is 54 participants, below the 3,028-participant average among 338 other Diabetes trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT00339833, a Phase 4 study of Diabetes and Type 2 Diabetes, has completed, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).

COMPLETED
Registry status
Phase 4
Development phase
54 participants
Enrollment target
1
Study location

Study Summary

This study, conducted at the Phoenix Indian Medical Center, Phoenix, Arizona, will determine whether reducing subclinical inflammation lessens insulin resistance in healthy, obese volunteers. The study findings may lead to new strategies for preventing type 2 diabetes. In diabetes, blood sugar is higher than normal and can result in serious medical problems, such as blindness and kidney failure. People with subclinical inflammation-inflammation that does not produce symptoms, such as fever, pain, or skin redness-are at increased risk for diabetes. Although the reasons for this are not completely understood, it is known that subclinical inflammation exacerbates insulin resistance, which is a cause of diabetes. Insulin is a hormone that helps control blood sugar, and when it does not work properly, the condition is known as insulin resistance. Normal, healthy volunteers between 18 and 45 years old with a body mass index of at least 30 kg/m2 and who have subclinical inflammation (determined by blood tests) may be eligible for this study. Candidates must be non-smokers and must not have an alcohol or drug problem. Candidates will be screened with a medical history and physical examination, electrocardiogram, and blood and urine tests. Participants will maintain a standard diet and undergo tests and procedures during a 14-day inpatient stay at the Phoenix Indian Medical Center.

Conditions Studied

Interventions

  • DRUG Placebo
  • DRUG Salsalate

Study Locations (1)

Arizona

  • NIDDK, Phoenix - Phoenix

Trial Details

FieldValue
Enrollment Target 54 participants
Start Date 2003-03
Est. Completion 2008-07
Phase Phase 4

What the Registry Record Tells You About NCT00339833

The ClinicalTrials.gov registry entry for NCT00339833 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 54 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 3,028-participant average among 338 other Diabetes trials with a reported enrollment target (98% lower). The listed sponsor is National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), which has 490 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Diabetes appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.

NCT00339833 reports 1 study location spanning 1 distinct geographic area - top geographies include Arizona.

Frequently Asked Questions

What is clinical trial NCT00339833 about?

NCT00339833 is a clinical study titled "The Effects of Anti-Inflammatory Treatment on Insulin Resistance in Healthy Volunteers". This study, conducted at the Phoenix Indian Medical Center, Phoenix, Arizona, will determine whether reducing subclinical inflammation lessens insulin resistance in healthy, obese volunteers. The study findings may lead to new strategies for preventing type 2 diabetes. In diabetes, blood sugar is hi...

What is the current status of trial NCT00339833?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 54 participants. The study started on 2003-03. Estimated completion is 2008-07.

What conditions does trial NCT00339833 study?

This clinical trial studies the following conditions: Diabetes, Type 2 Diabetes.

What interventions are being tested in trial NCT00339833?

The interventions under investigation include: Placebo (DRUG), Salsalate (DRUG).

Who is sponsoring clinical trial NCT00339833?

This trial is sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), which has 490 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00339833 being conducted?

This trial has 1 study location across Arizona. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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