Gastrointestinal Hormones and Metabolomic Profiling Following Mixed-Meal Tolerance Tests in Patients at Risk of Refeeding Syndrome

NCT07674589 | Not Yet Recruiting

• 1 other identifier: Hospital Garcia de Orta
• Study Type: observational
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

Introduction: Refeeding syndrome (RS) is a life-threatening metabolic complication of nutritional support. Prolonged fasting, frequently observed in malnourished patients referred for percutaneous endoscopic gastrostomy (PEG), induces histological and ultrastructural changes in the intestinal mucosa, potentially influencing RS development. Mixed-Meal Tolerance Tests (MMTT) combined with metabolomics allow dynamic assessment of serum glucose, gastrointestinal hormones and cellular metabolites, which may help to elucidate RS pathogenesis and assess patient risk. Objective: The present study aims to perform MMTT in PEG-fed patients to evaluate enteroendocrine hormone responses and metabolomic profiles following a prolonged fasting period and subsequent enteral refeeding. Methods: This prospective, single-center study includes adults referred for PEG after at least one month of oral intake below 50% of energy needs. The MMTT will be performed at PEG placement and after 3-6 months of enteral nutrition. Serial blood samples will be collected from baseline up to 120 minutes post-meal to measure serum glucose, insulin, C-peptide, electrolytes and gastrointestinal hormones (GLP-1/GIP/Ghrelin/Peptide YY), and for metabolomic profiling by spectroscopy. Clinical and nutritional data will be prospectively recorded. Statistical and multivariate analyses will assess metabolic and hormonal changes over time and their potential association with patient refeeding syndrome risk and clinical outcome. The study was approved by the institutional ethics committee, and patient informed consent will be obtained. Conclusion: This study integrates MMTT and metabolomic profiling to characterize hormonal and metabolic responses during fasting and refeeding in high-risk PEG patients. Findings are expected to reveal underlying mechanisms of RS, identify potential predictive biomarkers, and improve individualized risk stratification and nutritional management.

Conditions

Refeeding Syndrome; Malnutrition

Keywords

Refeeding Syndrome; Gastrointestinal Hormones; Metabolomics; Mixed-Meal Tolerance Tests; PEG

Outcome Measures

Primary Outcomes (4)

• To define the kinetics of serum glucose, electrolytes and gastrointestinal hormones during fasting and refeeding.

  From enrollment to the end of the study at 3-6 months.

• To perform MMTT and metabolomic analysis to patients referred for endoscopic gastrostomy after a significant period of low ingestion.

  At the time of the inclusion

• To repeat the same evaluation after 3-6 months of long-term enteral nutrition with adequate energy supply.

  At 3-6 months after inclusion

• To analyze the evolution of serum metabolites during fasting and refeeding aiming to identify potential predictive biomarkers of RS development in high-risk patients.

  From enrollment to the end of the study at 3-6 months.

Study Arms (1)

Ambulatory patients referred to percutaneous endoscopic gastrostomy for long-term enteral nutrition.

Adult patients (age above 18 years) with oral ingestion below 50% of energy daily needs for a minimum period of 1 month and absence of any form of artificial nutrition (oral supplements, tube feeding or parenteral nutrition) before percutaneous endoscopic gastrostomy.

Eligibility Criteria

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

Study Population

Ambulatory patients referred to PEG for long-term enteral nutrition.

You may qualify if:

• Age above 18 years.
• Oral ingestion below 50% of energy daily needs for ≥ 1 month.
• Absence of artificial nutrition before PEG placement.

You may not qualify if:

• Age below 18 years.
• Quantified food ingestion above 50% of energy daily needs during the last month.
• Oncologic disease.
• Diabetes mellitus.
• Expected survival below 3 months.
• Inability to provide credible anamnestic data.
• Impossibility to have an appropriate clinical and nutritional follow-up.

Sponsors & Collaborators

• Hospital Garcia de Orta: lead
• Instituto de Ciências Biomédicas Abel Salazar: collaborator

Study Sites (1)

Hospital Garcia de Orta

Almada, Setúbal District, 2670-487, Portugal

Location

Related Publications (22)

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• Nunes G, Guimaraes M, Coelho H, Carregosa R, Oliveira C, Pereira SS, Alves de Matos A, Fonseca J. Prolonged Fasting Induces Histological and Ultrastructural Changes in the Intestinal Mucosa That May Reduce Absorption and Revert after Enteral Refeeding. Nutrients. 2023 Dec 30;16(1):128. doi: 10.3390/nu16010128.

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Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood samples

MeSH Terms

Conditions

Refeeding Syndrome; Malnutrition

Condition Hierarchy (Ancestors)

Nutrition Disorders; Nutritional and Metabolic Diseases

Study Officials

• Gonçalo Nunes, MD

  Gastroenterology Department, GENE - Artificial Feeding Team, Unidade Local de Saúde Almada-Seixal, Hospital Garcia de Orta, Almada, Portugal.

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gonçalo Nunes, MD, MSc

CONTACT

00351965492185; goncalo.n@hotmail.com

Jorge Fonseca, MD, MSc, PhD

CONTACT

jorgedafonseca@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Study Record Dates

• First Submitted: June 22, 2026
• First Posted: June 29, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: June 29, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

PT (1)