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

September 2, 2020 updated by: Dr. Vanessa Fuchs Tarlovsky, Hospital General de Mexico

Effect of Supplementation With b- Hydroxy Methyl Butyrate and Glutamine in Wound Healing Histology in Type 2 Diabetes and Controls Bloody Areas

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Mexico
      • Mexico City, Mexico
        • Hospital General de México

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • Calcic caseinate

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
15 days

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
15 days
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)
15 days
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)
15 days
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)
15 days
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.
15 days
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.
15 days
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.
15 days
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.
15 days
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,
15 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital General de Mexico

Investigators

  • Principal Investigator: Vanessa Fuchs, PhD, Hospital General de México

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

June 1, 2021

Primary Completion (Anticipated)

August 1, 2021

Study Completion (Anticipated)

December 31, 2021

Study Registration Dates

First Submitted

October 15, 2018

First Submitted That Met QC Criteria

December 18, 2018

First Posted (Actual)

December 20, 2018

Study Record Updates

Last Update Posted (Actual)

September 3, 2020

Last Update Submitted That Met QC Criteria

September 2, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DI/17/111/03/014

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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