Clinical trial NCT03782155: 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
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Wound Healing
Diabetic
Keywords: wound healing, diabetes wound healing
Lead sponsor: Hospital General de Mexico
Sponsor class: OTHER_GOV
First posted: 2018-12-20
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A randomized clinical trial study
Primary purpose: TREATMENT

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.

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)

Primary outcomes:
measure: Wound healing:Number of cells per clauster in tissue sample of wound.
timeFrame: 15 days
Secondary outcomes:
Other outcomes:
measure: Bates- Jensen wound tool
timeFrame: 15 days
measure: Biochemical serum values of CPR
timeFrame: 15 days
measure: Biochemical serum values of creatinine
timeFrame: 15 days
measure: Biochemical serum values of procalcitonine
timeFrame: 15 days
measure: Bacterial growth per clauster in culture wound
timeFrame: 15 days
measure: Type of bacterial growth in wound
timeFrame: 15 days
measure: Glucemic control by glucose
timeFrame: 15 days
measure: Glucemic control by HbA1c
timeFrame: 15 days
measure: Incidence of treatment- adverse events
timeFrame: 15 days
Locations:
city: Mexico City
country: Mexico
facility: Hospital General de México
Study officials:
affiliation: Hospital General de México
name: Vanessa Fuchs, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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