Nutritional Regulation of Wound Inflammation: Part II

Completed

Conditions studied: Diabetes

In brief

Fermented Papaya Preparation (FPP) is a sweet and granular substance available over the counter. FPP possesses antioxidant properties, which provide benefit against age-related complications, and is also known to protect red blood cells (RBCs) against oxidative damage and to help protect against severe forms of thalassemia. The investigators recently showed that ex vivo supplementation of FPP can correct respiratory burst performance of diabetic peripheral blood mononuclear cells (PBMC) via a Sp-1 dependant pathway. Based on these observations, the investigators propose to study the outcome that FPP supplementation has in patients with diabetes.

Key facts

Study ID

NCT01618045

Run by

Ohio State University

People needed

24

Starts

2012-05-01

Expected to finish

2015-02-19

Last updated by the study team

2019-07-23

Who can join

Age: 30 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Adult patients 30 to 80 years old with clinically defined type II diabetes and HbA1c ≤ 9.0 and BMI between 22 and 42
• Diabetic subjects selected for the study will meet one or more of the following criteria as recommended by American Diabetes Association:
• 1) Symptoms of diabetes and casual plasma glucose 200 mg/dl (11.1 mmol/l) (casual is defined as any time of day without regard to time since last meal. The classic symptoms of diabetes include polyuria, polydipsia, and unexplained weight loss); OR
• 2) Fasting plasma glucose (FPG) 126 mg/dl (7.0 mmol/l) (fasting is defined as no caloric intake for at least 8 h); OR
• 3) 2-hr plasma glucose 200 mg/dl (11.1 mmol/l) during an oral glucose tolerance test (OGTT) (this test should be performed as described by the World Health Organization, using a glucose load containing the equivalent of 75g anhydrous glucose dissolved in water)

You may not qualify if…

• Individuals who are deemed unable to understand the procedures, risks and benefits of the study (i.e., informed consent) will be excluded
• T2DM with HbA1c = 9.1 or above
• BMI less than 22 and over 42
• Clinically significant kidney or liver disease
• Severe neurologic dysfunction
• Females who are pregnant as well as individuals who are therapeutically immuno-compromised will also be excluded in order to minimize the risk to such individuals (and fetus) and to decrease statistical variability and to minimize the potential of confounders
• Candidates for inclusion into the study will not include individuals as defined in 45 CFR 46 Subparts B, C and D, nor from any other population which may be considered vulnerable
• Pregnant women are excluded to minimize the risk to such individuals (and fetus) and to decrease statistical variability and to minimize the potential of confounders

Where it is running

• OSU CarePoint East — Columbus, Ohio, United States
• University Hospital East (Wound Center) — Columbus, Ohio, United States
• University Hospital East, OSUWMC Diabetes Clinic — Columbus, Ohio, United States
• The Ohio State University/Ohio State University Wexner Medical Center — Columbus, Ohio, United States
• OSUWMC Comprehensive Wound Care Center, Martha Morehouse Medical Plaza — Columbus, Ohio, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.