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

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ClinicalTrials.gov Identifier: NCT03782155
Recruitment Status : Not yet recruiting
First Posted : December 20, 2018
Last Update Posted : September 3, 2020
Sponsor:
Information provided by (Responsible Party):
Dr. Vanessa Fuchs Tarlovsky, Hospital General de Mexico

Study Description
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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.

Condition or disease Intervention/treatment Phase
Wound Healing Diabetic Drug: glutamine supplementation Drug: HMB Drug: Placebo Phase 4

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: A randomized clinical trial study
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Supplementation With b- Hydroxy Methyl Butyrate and Glutamine in Wound Healing Histology in Type 2 Diabetes and Controls Bloody Areas
Estimated Study Start Date : June 1, 2021
Estimated Primary Completion Date : August 1, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Glutamine

Arms and Interventions
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Arm Intervention/treatment
Experimental: HMB and glutamine supplementation
Patients with type 2 diabetes with supplementation HMB 3g, powder once a day and glutamine powder 14g once a day supplementation during 15 days.
 Drug: glutamine supplementation
powder 14g
Other Name: Glutamine

Drug: HMB
powder 3g
Placebo Comparator: placebo patients
Patients with type 2 diabetes with placebo( calcium caseinate) supplementation during 15 days 17g of powder once a day
 Drug: Placebo
powder 17g
Other Name: Calcic caseinate


Outcome Measures
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Primary Outcome Measures :
  1. Wound healing:Number of cells per clauster in tissue sample of wound. [ Time Frame: 15 days ]
    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.


Other Outcome Measures:
  1. Bates- Jensen wound tool [ Time Frame: 15 days ]
    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

  2. Biochemical serum values of CPR [ Time Frame: 15 days ]
    To evaluate and compared the values of serum CPR, two different serum samples ( at the beginning and after finished the supplementation)

  3. Biochemical serum values of creatinine [ Time Frame: 15 days ]
    To evaluate and compared the values of serum creatinine, two different serum samples ( at the beginning and after finished the supplementation)

  4. Biochemical serum values of procalcitonine [ Time Frame: 15 days ]
    To evaluate and compared the values of serum procalcitonine, two different serum samples ( at the beginning and after finished the supplementation)

  5. Bacterial growth per clauster in culture wound [ Time Frame: 15 days ]
    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.

  6. Type of bacterial growth in wound [ Time Frame: 15 days ]
    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.

  7. Glucemic control by glucose [ Time Frame: 15 days ]
    Glucose control will be messured in serum sample (mg/dL) in two different moments: at the begining and after finished the supplementation.

  8. Glucemic control by HbA1c [ Time Frame: 15 days ]
    HbA1c(%) control will be messured in serum in two different moments: at the begining and after finished the supplementation.

  9. Incidence of treatment- adverse events [ Time Frame: 15 days ]
    Each day of supplementation will be performed a questionary about subjective syntoms( as abdominal pain, diarrhea, nausea, vomiting, constipation or others) of supplementation,


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03782155


Contacts
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Contact: Vanessa Fuchs, PhD 551 85331635 vanessafuchs@gmail.com

Locations
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Mexico
Hospital General de México
Mexico City, Mexico
Sponsors and Collaborators
Hospital General de Mexico
Investigators
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Principal Investigator: Vanessa Fuchs, PhD Hospital General de México
More Information
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Publications of Results:
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.

Other Publications:

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Responsible Party: Dr. Vanessa Fuchs Tarlovsky, Head of clinical nutrition, Hospital General de Mexico
ClinicalTrials.gov Identifier: NCT03782155    
Other Study ID Numbers: DI/17/111/03/014
First Posted: December 20, 2018    Key Record Dates
Last Update Posted: September 3, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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
Keywords provided by Dr. Vanessa Fuchs Tarlovsky, Hospital General de Mexico:
wound healing, diabetes wound healing
Additional relevant MeSH terms:
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Wounds and Injuries