Blood-Interstitial Fluid Glucose Gap

NCT07240103 | Completed DMC

• 1 other identifier: Glucose Gap
• Study Type: observational
• Target: 140
• Locations: 1 country
• Sites: 1

Brief Summary

Metabolic monitoring is fundamental to guiding nutritional therapy in critically ill patients. Although indirect calorimetry is the established gold standard for measuring resting energy expenditure, its routine clinical use is constrained by practical challenges, including procedural complexity, time-intensive nature, significant cost, and limited feasibility in patients on advanced life support, such as extracorporeal membrane oxygenation (ECMO). Dysregulation of glucose metabolism is common in this population, characterized not only by absolute dysglycemia but also-and perhaps more critically-by impairments in the efficiency of glucose transport and utilization across the microcirculatory continuum (from arterial blood, through the interstitial space, to venous return). This study seeks to examine the relationship between novel dynamic metrics-such as the arterio-interstitial glucose gradient-and key clinical parameters, including energy expenditure, organ function, and patient outcomes. Our objective is to assess the utility of these measures as minimally invasive, real-time biomarkers of metabolic state in critical illness.

Conditions

Critical Illness; Metabolism Disorders

Keywords

Glucose Gap; Metabolic Monitoring; Critically Ill Patients; Prognosis; Insulin Resistance

Outcome Measures

Primary Outcomes (1)

• ICU Mortality

  The incidence of all-cause death during the patient's stay in the Intensive Care Unit

  From date of study enrollment until the date of ICU discharge or date of death from any cause, whichever came first, assessed up to 60 days

Secondary Outcomes (3)

• Duration of Vasopressor Dependency

  From date of study enrollment until the date of vasopressor cessation for at least 24 hours, assessed up to 30 days

• Duration of Invasive Mechanical Ventilation

  From date of study enrollment until the date of successful extubation, tracheostomy, or death from any cause, whichever came first, assessed up to 30 days

• Duration of Continuous Renal Replacement Therapy (CRRT)

  From date of study enrollment until the date of CRRT discontinuation for at least 24 hours or death from any cause, whichever came first, assessed up to 30 days

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

critically ill patient

You may qualify if:

• Age≥ 18 years and \< 80 years
• ICU stay ≤48 hours
• Expected ICU stay \> 24 hours
• APACHE II score≥ 8

You may not qualify if:

• local infection within the sensor placement area
• Laparotomy within lower abdomen
• Participated in this study before
• In other clinical trails

Sponsors & Collaborators

• Chinese Medical Association: lead

Study Sites (1)

Nanjing Drum Tower Hospital

Nanjing, Jiangsu, 210000, China

Location

Related Publications (18)

• Houben AJHM, Martens RJH, Stehouwer CDA. Assessing Microvascular Function in Humans from a Chronic Disease Perspective. J Am Soc Nephrol. 2017 Dec;28(12):3461-3472. doi: 10.1681/ASN.2017020157. Epub 2017 Sep 13.

  PMID: 28904002 RESULT

• Gouvea Bogossian E, Taleb C, Aspide R, Badenes R, Battaglini D, Bilotta F, Blandino Ortiz A, Caricato A, Castioni CA, Citerio G, Ferraro G, Martino C, Melchionda I, Montanaro F, Monleon Lopez B, Nato CG, Piagnerelli M, Picetti E, Robba C, Simonet O, Thooft A, Taccone FS. Cerebro-spinal fluid glucose and lactate concentrations changes in response to therapies in patIents with primary brain injury: the START-TRIP study. Crit Care. 2023 Mar 31;27(1):130. doi: 10.1186/s13054-023-04409-6.

  PMID: 37004053 RESULT

• Evans L, Rhodes A, Alhazzani W, Antonelli M, Coopersmith CM, French C, Machado FR, Mcintyre L, Ostermann M, Prescott HC, Schorr C, Simpson S, Wiersinga WJ, Alshamsi F, Angus DC, Arabi Y, Azevedo L, Beale R, Beilman G, Belley-Cote E, Burry L, Cecconi M, Centofanti J, Coz Yataco A, De Waele J, Dellinger RP, Doi K, Du B, Estenssoro E, Ferrer R, Gomersall C, Hodgson C, Hylander Moller M, Iwashyna T, Jacob S, Kleinpell R, Klompas M, Koh Y, Kumar A, Kwizera A, Lobo S, Masur H, McGloughlin S, Mehta S, Mehta Y, Mer M, Nunnally M, Oczkowski S, Osborn T, Papathanassoglou E, Perner A, Puskarich M, Roberts J, Schweickert W, Seckel M, Sevransky J, Sprung CL, Welte T, Zimmerman J, Levy M. Surviving Sepsis Campaign: International Guidelines for Management of Sepsis and Septic Shock 2021. Crit Care Med. 2021 Nov 1;49(11):e1063-e1143. doi: 10.1097/CCM.0000000000005337. No abstract available.

  PMID: 34605781 RESULT

• Nuyttens L, Heyerick M, Heremans G, Moens E, Roes M, Van Dender C, De Bus L, Decruyenaere J, Dewaele J, Vandewalle J, Libert C. Unraveling mitochondrial pyruvate dysfunction to mitigate hyperlactatemia and lethality in sepsis. Cell Rep. 2025 Aug 26;44(8):116032. doi: 10.1016/j.celrep.2025.116032. Epub 2025 Jul 21.

  PMID: 40694477 RESULT

• Jaiswal N, Gavin MG, Quinn WJ 3rd, Luongo TS, Gelfer RG, Baur JA, Titchenell PM. The role of skeletal muscle Akt in the regulation of muscle mass and glucose homeostasis. Mol Metab. 2019 Oct;28:1-13. doi: 10.1016/j.molmet.2019.08.001. Epub 2019 Aug 5.

  PMID: 31444134 RESULT

• Marik PE, Bellomo R. Stress hyperglycemia: an essential survival response! Crit Care Med. 2013 Jun;41(6):e93-4. doi: 10.1097/CCM.0b013e318283d124. No abstract available.

  PMID: 23685597 RESULT

• Mahdavi S, Anthony NM, Sikaneta T, Tam PY. Perspective: Multiomics and Artificial Intelligence for Personalized Nutritional Management of Diabetes in Patients Undergoing Peritoneal Dialysis. Adv Nutr. 2025 Mar;16(3):100378. doi: 10.1016/j.advnut.2025.100378. Epub 2025 Jan 20.

  PMID: 39842720 RESULT

• Achamrah N, Delsoglio M, De Waele E, Berger MM, Pichard C. Indirect calorimetry: The 6 main issues. Clin Nutr. 2021 Jan;40(1):4-14. doi: 10.1016/j.clnu.2020.06.024. Epub 2020 Jul 2.

  PMID: 32709554 RESULT

• De Waele E, van Zanten ARH. Routine use of indirect calorimetry in critically ill patients: pros and cons. Crit Care. 2022 May 5;26(1):123. doi: 10.1186/s13054-022-04000-5. No abstract available.

  PMID: 35513872 RESULT

• Moonen HPFX, Beckers KJH, van Zanten ARH. Energy expenditure and indirect calorimetry in critical illness and convalescence: current evidence and practical considerations. J Intensive Care. 2021 Jan 12;9(1):8. doi: 10.1186/s40560-021-00524-0.

  PMID: 33436084 RESULT

• Graf S, Karsegard VL, Viatte V, Heidegger CP, Fleury Y, Pichard C, Genton L. Evaluation of three indirect calorimetry devices in mechanically ventilated patients: which device compares best with the Deltatrac II((R))? A prospective observational study. Clin Nutr. 2015 Feb;34(1):60-5. doi: 10.1016/j.clnu.2014.01.008. Epub 2014 Jan 21.

  PMID: 24485773 RESULT

• Lakenman PLM, van der Hoven B, van Bommel J, Olieman JF, Joosten KFM. The usefulness of a new indirect calorimeter in critically ill adult patients. Clin Nutr. 2024 Oct;43(10):2267-2272. doi: 10.1016/j.clnu.2024.07.048. Epub 2024 Aug 7.

  PMID: 39208718 RESULT

• de Goes CR, Berbel-Bufarah MN, Sanches AC, Xavier PS, Balbi AL, Ponce D. Poor Agreement between Predictive Equations of Energy Expenditure and Measured Energy Expenditure in Critically Ill Acute Kidney Injury Patients. Ann Nutr Metab. 2016;68(4):276-84. doi: 10.1159/000446708. Epub 2016 Jun 10.

  PMID: 27288392 RESULT

• Harris JA, Benedict FG. A Biometric Study of Human Basal Metabolism. Proc Natl Acad Sci U S A. 1918 Dec;4(12):370-3. doi: 10.1073/pnas.4.12.370. No abstract available.

  PMID: 16576330 RESULT

• Zusman O, Theilla M, Cohen J, Kagan I, Bendavid I, Singer P. Resting energy expenditure, calorie and protein consumption in critically ill patients: a retrospective cohort study. Crit Care. 2016 Nov 10;20(1):367. doi: 10.1186/s13054-016-1538-4.

  PMID: 27832823 RESULT

• Singer P, Bendavid I, BenArie I, Stadlander L, Kagan I. Feasibility of achieving different protein targets using a hypocaloric high-protein enteral formula in critically ill patients. Crit Care. 2021 Jun 11;25(1):204. doi: 10.1186/s13054-021-03625-2.

  PMID: 34116714 RESULT

• Allingstrup MJ, Kondrup J, Wiis J, Claudius C, Pedersen UG, Hein-Rasmussen R, Bjerregaard MR, Steensen M, Jensen TH, Lange T, Madsen MB, Moller MH, Perner A. Early goal-directed nutrition versus standard of care in adult intensive care patients: the single-centre, randomised, outcome assessor-blinded EAT-ICU trial. Intensive Care Med. 2017 Nov;43(11):1637-1647. doi: 10.1007/s00134-017-4880-3. Epub 2017 Sep 22.

  PMID: 28936712 RESULT

• Arabi YM, Casaer MP, Chapman M, Heyland DK, Ichai C, Marik PE, Martindale RG, McClave SA, Preiser JC, Reignier J, Rice TW, Van den Berghe G, van Zanten ARH, Weijs PJM. The intensive care medicine research agenda in nutrition and metabolism. Intensive Care Med. 2017 Sep;43(9):1239-1256. doi: 10.1007/s00134-017-4711-6. Epub 2017 Apr 3.

  PMID: 28374096 RESULT

MeSH Terms

Conditions

Critical Illness; Metabolic Diseases; Insulin Resistance

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Hyperinsulinism; Glucose Metabolism Disorders

Study Officials

• Wenkui Yu, Professor

  The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 13, 2025
• First Posted: November 20, 2025
• Study Start: July 13, 2023
• Primary Completion: March 13, 2024
• Study Completion: October 1, 2025
• Last Updated: November 20, 2025

Record last verified: 2025-10

Locations

CN (1)