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

Hospital General de Mexico

Status and phase: Unknown; Phase 4

Conditions: Diabetic; Wound Healing

Treatments: Drug: HMB; Drug: glutamine supplementation; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT03782155

DI/17/111/03/014

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No 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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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30 participants in 2 patient groups, including a placebo group

HMB and glutamine supplementation

Experimental group

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.

Treatment:

Drug: glutamine supplementation

Drug: HMB

placebo patients

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo