Diabetic Foot Surgery Patients: What is Their Metabolic Profile and Are Nutritional Goals Met

NCT04247451 | Suspended

• 1 other identifier: BUN 143201941164
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Prospective interventional follow-up of diabetic foot surgery patients, their metabolic/nutritional profile, and the nutritional adequacy in the perioperative setting. Primary objective: to establish the preoperative metabolic profile of diabetic patients scheduled for foot surgery and determine the postoperative nutritional status. The daily values of caloric intake compared to caloric need and protein intake compared to protein need will be evaluated as primary endpoint. \[Actual daily caloric and protein intake is compared to the calculated need.\] These values will each be presented as relative %. Wound healing is an anabolic process that requires ample access to nutrients. Insulin is considered the main anabolic hormone of the body, and regulates the metabolism of carbohydrates, fats and proteins. Diabetic patients lack this very hormone, and in addition are required to follow a strict dietary regime that further limits caloric and protein intake. Very little research had been done to evaluate the role of malnutrition in delayed wound healing. Overall: What is the metabolic/nutritional profile of a diabetes patient with foot wounds undergoing surgery? Is the intake of proteins and caloric adequate in the perioperative setting and are nutritional goals met? Is there a possibility for iatrogenic malnutrition? What kind of nutrition would possibly be useful to optimize intake?

Conditions

Diabetic Foot Ulcer; Nutrition Disorders

Outcome Measures

Primary Outcomes (1)

• Efficiency of nutritional therapy: Dietary intake (food diary; in Kcal) compared to caloric need (indirect calorimetry; Kcal)

  Actual daily caloric and protein intake compared to the calculated need. These values will each be presented as relative %.

  an average of 3 weeks (perioperative period)

Secondary Outcomes (2)

• Caloric needs (indirect calorimetry; Kcal) in diabetic foot surgery

  an average of 3 weeks (perioperative period)

• Evaluation of choice for oral nutritional supplements, enteral nutrition and parenteral nutrition (%)

  an average of 3 weeks (perioperative period)

Study Arms (1)

Interventional group

EXPERIMENTAL

Nutritional intake: these data will be evaluated daily during preoperative hospitalization, at home, and during the actual hospitalization, from surgical intervention to discharge. Before the follow-up consultation, patients will keep a food diary. The dieticians will calculate intake and need. Metabolic data: body composition using BIA (Nutrilab Akern) and REE using indirect calorimetry (Cosmed Q NRG) will be analyzed in three timepoints: preoperative, postoperative and at follow-up consultation. This measurements take maximum ten minutes and do not cause discomfort to the participants.

Diagnostic Test: Metabolic profile and nutritional goals in diabetic foot surgery patients

Interventions

Metabolic profile and nutritional goals in diabetic foot surgery patients DIAGNOSTIC_TEST

Nutritional intake: these data will be evaluated daily during preoperative hospitalization, at home, and during the actual hospitalization, from surgical intervention to discharge. Before the follow-up consultation, patients will keep a food diary. The dieticians will calculate intake and need. Metabolic data: body composition using Bio electrical Impedance Analysis BIA (Nutrilab Akern) and Resting Energy Expenditure REE using indirect calorimetry (Cosmed Q NRG) will be analysed in three timepoints: preoperative, postoperative and at follow-up consultation. This measurements take maximum ten minutes and do not cause discomfort to the participants.

Interventional group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \> 18years
• under oral or insulin therapy for diabetes mellitus
• patient recruitment at the multidisciplinary at the diabetic wound clinic of the University Hospital Brussel
• scheduled for surgery, with an indication related to the wound(s).

You may not qualify if:

• Presence of other metabolic diseases (inborn/acquired such as hyperthyroidism)
• Incapacity to undergo research investigations (relative CI to body composition measurement by Bio electrical impedance BIA: cardiac defibrillator)
• Limb- or life threatening disease
• Patient or relatives is/are unable to accurately record dietary intake

Sponsors & Collaborators

• Universitair Ziekenhuis Brussel: lead

Study Sites (1)

UZ Brussel

Brussels, Belgium

Location

MeSH Terms

Conditions

Diabetic Foot; Nutrition Disorders

Interventions

Metabolome

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Metabolism

Study Officials

• Elisabeth De Waele, MD, PhD

  Universitair Ziekenhuis Brussel

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Clinics ICU

Study Record Dates

• First Submitted: January 8, 2020
• First Posted: January 30, 2020
• Study Start: January 1, 2020
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2024
• Last Updated: May 9, 2024

Record last verified: 2024-05

Locations

BE (1)