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Effect of Supplementation With HMB and Glutamine in Wound Healing on Bloody Areas

Primary Purpose

Wound Healing, Diabetic

Status
Unknown status
Phase
Phase 4
Locations
Mexico
Study Type
Interventional
Intervention
glutamine supplementation
HMB
Placebo
Sponsored by
Hospital General de Mexico
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Wound Healing focused on measuring wound healing, diabetes wound healing

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients with bloody areas at hospital admission
  • Hospital length stay around 15 days
  • Medical treatment with surgical washing and negative pressure systems
  • For the groups with diabetes, patients with diagnosis of type 2 diabetes with bloody areas.
  • Patients that accepts and signs the informative consent.

Exclusion Criteria:

  • patients with cancer or immunodeficiency
  • patients with HbA1c < 12
  • patients with collagen disease
  • patients with allergy to intervention substances (HMB, glutamine)

Sites / Locations

  • Hospital General de México

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

HMB and glutamine supplementation

placebo patients

Arm Description

Patients with type 2 diabetes with supplementation HMB 3g, powder once a day and glutamine powder 14g once a day supplementation during 15 days.

Patients with type 2 diabetes with placebo( calcium caseinate) supplementation during 15 days 17g of powder once a day

Outcomes

Primary Outcome Measures

Wound healing:Number of cells per clauster in tissue sample of wound.
To evaluate the effect of supplementation in cellular differentiation. It will be counted and compared the number of cells per cluster in a tissue sample (lymphocytes, fibroblasts , macrophages and angiogeny) at the begining and after the supplementation.

Secondary Outcome Measures

Full Information

First Posted
October 15, 2018
Last Updated
September 2, 2020
Sponsor
Hospital General de Mexico
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1. Study Identification

Unique Protocol Identification Number
NCT03782155
Brief Title
Effect of Supplementation With HMB and Glutamine in Wound Healing on Bloody Areas
Official Title
Effect of Supplementation With b- Hydroxy Methyl Butyrate and Glutamine in Wound Healing Histology in Type 2 Diabetes and Controls Bloody Areas
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Unknown status
Study Start Date
June 1, 2021 (Anticipated)
Primary Completion Date
August 1, 2021 (Anticipated)
Study Completion Date
December 31, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital General de Mexico

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
A randomized controlled clinical trial in two groups of supplementation with HMB and glutamine. Each group consist in 25 patients with bloody areas, one group will receive and intervention with HMB and Glutamine and the other will receive a placebo with calcium caseinate.
Detailed Description
A fundamental part of the integral management of wound healing in patients with bloody areas is nutrition, since it involves biochemical events that depend on the substrates it provides. Wound healing is a phase that demands higher needs of energy-protein than the requirement. Problem statement: Poor nutrition decreases, through specific phases, normal processes that allow the progression of wound healing. Nutrient deficiencies can have negative effects on wound healing by prolonging the inflammatory phase, decreasing fibroblast proliferation, and modifying collagen synthesis. Some amino acids are essential for the process, such as Glutamine and Hydroxymethylbutyrate. Objective: To evaluate the effect of Glutamine and Hydroxymethylbutyrate supplementation over the cells involved in wound healing of bloody areas. Hypothesis: Glutamine and Hydroxymethylbutyrate supplementation promotes a positive effect over the cells involved in wound healing of bloody areas. Methodology: A randomized controlled clinical trial, in patients with diagnosis of bloody areas. They will be divided into two groups, the first will receive an intervention with Glutamine (14g) and Hydroxymethylbutyrate (3g) and a control group will receive a placebo with calcium caseinate (17g) A sample of the affected tissue will be taken before and after the supplementation where histology will be analyzed. Remains of tissue will be obteined during surgery wash for histology.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Wound Healing, Diabetic
Keywords
wound healing, diabetes wound healing

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
A randomized clinical trial study
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
HMB and glutamine supplementation
Arm Type
Experimental
Arm Description
Patients with type 2 diabetes with supplementation HMB 3g, powder once a day and glutamine powder 14g once a day supplementation during 15 days.
Arm Title
placebo patients
Arm Type
Placebo Comparator
Arm Description
Patients with type 2 diabetes with placebo( calcium caseinate) supplementation during 15 days 17g of powder once a day
Intervention Type
Drug
Intervention Name(s)
glutamine supplementation
Other Intervention Name(s)
Glutamine
Intervention Description
powder 14g
Intervention Type
Drug
Intervention Name(s)
HMB
Intervention Description
powder 3g
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Calcic caseinate
Intervention Description
powder 17g
Primary Outcome Measure Information:
Title
Wound healing:Number of cells per clauster in tissue sample of wound.
Description
To evaluate the effect of supplementation in cellular differentiation. It will be counted and compared the number of cells per cluster in a tissue sample (lymphocytes, fibroblasts , macrophages and angiogeny) at the begining and after the supplementation.
Time Frame
15 days
Other Pre-specified Outcome Measures:
Title
Bates- Jensen wound tool
Description
To compared Bates- Jensen questionnaire will be applied two evaluations: first will be done before supplementation and second after finished the supplementation this scale consider physical characteristics of wound and give a punctuation 1 to 5 in each item ( size, depht, borders, necrosis, percentage of necrotic tissue , type of exudate, amount of exudate, skin color, edema, induration, granular tissue,epithelialization) according to this, items have a value that will be considered in a total punctuation of wound Punctuation 1-12 Health tissue 13- 59 regeneration 60. Degeneration
Time Frame
15 days
Title
Biochemical serum values of CPR
Description
To evaluate and compared the values of serum CPR, two different serum samples ( at the beginning and after finished the supplementation)
Time Frame
15 days
Title
Biochemical serum values of creatinine
Description
To evaluate and compared the values of serum creatinine, two different serum samples ( at the beginning and after finished the supplementation)
Time Frame
15 days
Title
Biochemical serum values of procalcitonine
Description
To evaluate and compared the values of serum procalcitonine, two different serum samples ( at the beginning and after finished the supplementation)
Time Frame
15 days
Title
Bacterial growth per clauster in culture wound
Description
It will be taken a bacterial culture of wound in two different moments ( at the beginning and after finished the supplementation) Will be counted the colony number per clauster and type of bacteria.
Time Frame
15 days
Title
Type of bacterial growth in wound
Description
It will be taken a bacterial culture of wound in two different moments ( at the beginning and after finished the supplementation) will be counted the kind of bacteria.
Time Frame
15 days
Title
Glucemic control by glucose
Description
Glucose control will be messured in serum sample (mg/dL) in two different moments: at the begining and after finished the supplementation.
Time Frame
15 days
Title
Glucemic control by HbA1c
Description
HbA1c(%) control will be messured in serum in two different moments: at the begining and after finished the supplementation.
Time Frame
15 days
Title
Incidence of treatment- adverse events
Description
Each day of supplementation will be performed a questionary about subjective syntoms( as abdominal pain, diarrhea, nausea, vomiting, constipation or others) of supplementation,
Time Frame
15 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with bloody areas at hospital admission Hospital length stay around 15 days Medical treatment with surgical washing and negative pressure systems For the groups with diabetes, patients with diagnosis of type 2 diabetes with bloody areas. Patients that accepts and signs the informative consent. Exclusion Criteria: patients with cancer or immunodeficiency patients with HbA1c < 12 patients with collagen disease patients with allergy to intervention substances (HMB, glutamine)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Vanessa Fuchs, PhD
Phone
551 85331635
Email
vanessafuchs@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vanessa Fuchs, PhD
Organizational Affiliation
Hospital General de México
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital General de México
City
Mexico City
Country
Mexico

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
20692599
Citation
Wild T, Rahbarnia A, Kellner M, Sobotka L, Eberlein T. Basics in nutrition and wound healing. Nutrition. 2010 Sep;26(9):862-6. doi: 10.1016/j.nut.2010.05.008.
Results Reference
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PubMed Identifier
27556777
Citation
Molnar JA, Vlad LG, Gumus T. Nutrition and Chronic Wounds: Improving Clinical Outcomes. Plast Reconstr Surg. 2016 Sep;138(3 Suppl):71S-81S. doi: 10.1097/PRS.0000000000002676.
Results Reference
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PubMed Identifier
20130158
Citation
Stechmiller JK. Understanding the role of nutrition and wound healing. Nutr Clin Pract. 2010 Feb;25(1):61-8. doi: 10.1177/0884533609358997.
Results Reference
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PubMed Identifier
26826258
Citation
Gundogdu RH, Temel H, Bozkirli BO, Ersoy E, Yazgan A, Yildirim Z. Mixture of Arginine, Glutamine, and beta-hydroxy-beta-methyl Butyrate Enhances the Healing of Ischemic Wounds in Rats. JPEN J Parenter Enteral Nutr. 2017 Aug;41(6):1045-1050. doi: 10.1177/0148607115625221. Epub 2016 Jan 29.
Results Reference
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PubMed Identifier
24463351
Citation
Bozkirli BO, Gundogdu RH, Ersoy E, Lortlar N, Yildirim Z, Temel H, Oduncu M, Karakaya J. Pilot Experimental Study on the Effect of Arginine, Glutamine, and beta-Hydroxy beta-Methylbutyrate on Secondary Wound Healing. JPEN J Parenter Enteral Nutr. 2015 Jul;39(5):591-7. doi: 10.1177/0148607113520433. Epub 2014 Jan 24.
Results Reference
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PubMed Identifier
24867069
Citation
Armstrong DG, Hanft JR, Driver VR, Smith AP, Lazaro-Martinez JL, Reyzelman AM, Furst GJ, Vayser DJ, Cervantes HL, Snyder RJ, Moore MF, May PE, Nelson JL, Baggs GE, Voss AC; Diabetic Foot Nutrition Study Group. Effect of oral nutritional supplementation on wound healing in diabetic foot ulcers: a prospective randomized controlled trial. Diabet Med. 2014 Sep;31(9):1069-77. doi: 10.1111/dme.12509. Epub 2014 Jun 19.
Results Reference
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PubMed Identifier
24810310
Citation
Wong A, Chew A, Wang CM, Ong L, Zhang SH, Young S. The use of a specialised amino acid mixture for pressure ulcers: a placebo-controlled trial. J Wound Care. 2014 May;23(5):259-60, 262-4, 266-9. doi: 10.12968/jowc.2014.23.5.259.
Results Reference
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PubMed Identifier
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Citation
Harris C, Bates-Jensen B, Parslow N, Raizman R, Singh M, Ketchen R. Bates-Jensen wound assessment tool: pictorial guide validation project. J Wound Ostomy Continence Nurs. 2010 May-Jun;37(3):253-9. doi: 10.1097/WON.0b013e3181d73aab.
Results Reference
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Citation
Salas-Gonzalez P, Sevilla- Gonzalez M de la L, Fuchs- Tarlovsky V. Effect of supplementation with glutamine and hydroxymethylbutirate over the cellsinvolved un wound healing. Int J Adv Res. 2018 Aug 31;6(8):100-6.
Results Reference
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PubMed Identifier
23311725
Citation
Sipahi S, Gungor O, Gunduz M, Cilci M, Demirci MC, Tamer A. The effect of oral supplementation with a combination of beta-hydroxy-beta-methylbutyrate, arginine and glutamine on wound healing: a retrospective analysis of diabetic haemodialysis patients. BMC Nephrol. 2013 Jan 12;14:8. doi: 10.1186/1471-2369-14-8.
Results Reference
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PubMed Identifier
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Citation
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Results Reference
result

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Effect of Supplementation With HMB and Glutamine in Wound Healing on Bloody Areas

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