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Nutritional Regulation of Wound Inflammation: Part II (FPPT2DM-II)

This study is currently recruiting participants.
Verified January 2013 by Ohio State University
Sponsor:
Collaborator:
Osato Research Foundation
Information provided by (Responsible Party):
Sashwati Roy, Ohio State University
ClinicalTrials.gov Identifier:
NCT01618045
First received: June 11, 2012
Last updated: January 18, 2013
Last verified: January 2013
History of Changes
  Purpose

Fermented papaya preparation (FPP)represents a sweet and granular substance available over the counter.FPP possesses antioxidant properties which provide benefit against age-related complications is also known to protect RBC against oxidative damage and help against severe forms of thalassemia. The investigators recently showed that ex vivo supplementation of FPP can correct respiratory burst performance of diabetic PBMC via a Sp-1 dependant pathway. Based on these observation, the investigators propose to study testing the outcome of FPP supplementation in diabetic patients.


Condition Intervention
Diabetes
 Dietary Supplement: Subject will take fermented papaya preparation for 6 weeks.

Study Type: Observational
Official Title: Nutritional Regulation Of Wound Inflammation: Part II

Resource links provided by NLM:

MedlinePlus related topics: Diabetes
U.S. FDA Resources

Further study details as provided by Ohio State University:

Primary Outcome Measures:
  • Blood glucose level . [ Time Frame: week 1 2, 6, 7 and 8. ] [ Designated as safety issue: Yes ]
    The blood glucose level will be measure on blood at different follow up visits.

  • HbA1c level [ Time Frame: initial visit, in two weeks and 6 weeks ] [ Designated as safety issue: Yes ]
    HbA1c level in blood will be measure in 3 visits to see any change in the level while taking supplementation.


Secondary Outcome Measures:
  • Lipid Profile [ Time Frame: Initial visit and 6 week. ] [ Designated as safety issue: No ]
    lipid profile will be measure in the blood in two visits.


Biospecimen Retention:   Samples Without DNA

Blood will be drawn for the study.


Estimated Enrollment: 20
Study Start Date: May 2012
Estimated Study Completion Date: May 2014
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
fermented papaya preparation
This a is single arm study.
 Dietary Supplement: Subject will take fermented papaya preparation for 6 weeks.
Subject will take fermented papaya preparation for 6 weeks. The subjects then will have blood draw five times total in their study period.
Other Name: IMMUN' AGE(F.P.P)

Detailed Description:

FPP possesses antioxidant properties which provide benefit against age-related complications. FPP is also known to protect RBC against oxidative damage and help against severe forms of thalassemia. Several independent observations convergently point towards the hypothesis that treatment with papaya preparations may facilitate wound healing responses. Chronic wounds represent a major public health problem in diabetics. Our previous studies have demonstrated that wound-site macrophages of diabetics are compromised in their ability to support wound healing. Recently, our laboratory reported first evidence demonstrating that FPP may improve diabetic wound outcomes by specifically influencing the response of wound-site macrophages and the subsequent angiogenic response. FPP has a long track record of safe human consumption. The objective of the current study is to determine whether FPP is able to improve inducible respiratory burst outcomes in peripheral blood mononuclear cells (PBMC) of diabetic. We have recently reported that supplementation of standardized fermented papaya preparation (FPP) to adult diabetic mice improves dermal wound healing outcomes. The production of reactive oxygen species (ROS) by type 2 diabetics (T2DM) PBMC is markedly inhibited compared to that of the PBMC from non-DM donors.

  Eligibility

Ages Eligible for Study:   30 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

The subject population in this study will be type 2 diabetes with following parameters.

  • with HbA1c ≤ 9. 0
  • BMI between 22-42
Criteria

Inclusion Criteria:

  • Adults patients (30-80 years old) with clinically defined type II diabetes and HbA1c ≤ 9. 0 and BMI between 22-42.
  • 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-h plasma glucose 200 mg/dl (11.1 mmol/l) during an oral glucose tolerance test (OGTT).
  • The 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

Exclusion Criteria:

  • 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 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 potential of confounders.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01618045

Contacts
Contact: Urmila Gnyawali, RN 614-366-3515 urmila.gnyawali@osumc.edu

Locations
United States, Ohio
The Ohio State University Recruiting
Columbus, Ohio, United States, 43210
Contact: Urmila Gnyawali, RN     614-366-3515     urmila.gnayawali@osumc.edu    
Sub-Investigator: Chandan k Sen, PhD            
Sub-Investigator: Gayle Gordillo, MD.            
University Hospita East (Wound center) Recruiting
Columbus, Ohio, United States, 43205
The OSU comprehensive Wond care center, Martha More house Recruiting
Columbus, Ohio, United States, 43221
OSU Care point East Recruiting
Columbus, Ohio, United States, 43203
University Hospital East, OSUMC Diabetic clinic Recruiting
Columbus, Ohio, United States, 43205
Sponsors and Collaborators
Ohio State University
Osato Research Foundation
Investigators
Principal Investigator: Sashwati Roy, PhD. Ohio State University
  More Information

No publications provided

Responsible Party: Sashwati Roy, Associate professor, Ohio State University
ClinicalTrials.gov Identifier: NCT01618045     History of Changes
Other Study ID Numbers: 20120293
Study First Received: June 11, 2012
Last Updated: January 18, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Ohio State University:
Diabetes.

Additional relevant MeSH terms:
Diabetes Mellitus
Inflammation
Glucose Metabolism Disorders
 Metabolic Diseases
Endocrine System Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on May 23, 2013