AzTrials
AzTrials

Nutritional SupplementNCT03277014

Using IGF-1 for Nutritional Monitoring

An observational study of Nutritional Supplement, run by Wang Xinying.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

Nutrition support is critical to a vast number of patients who are hospitalized annually because of critical illnesses or surgery. It is also necessary for patients with chronic intestinal failure (CIF), who often require parenteral nutrition over periods of weeks or months. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Nutritional Supplement
How many people
197 participants
Where
No sites listed yet
Study dates
Sep 2013to Jan 2017
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients treated at a single clinical nutrition center of a tertiary referral hospital in China to investigate whether the measurement of IGF-1 is useful for monitoring the efficiency of nutritional support and to explore the relationship between IGF-1 and lean body mass in CIF patients. The data used were accumulated at the center between September 2013 and January 2017.

Who may be able to join

  • All adult CIF patients (age ≥18 years) receiving nutrition support were included

Who cannot join

  • Hepatic insufficiency (alanine transaminase/aspartate transaminase ratio 200% above normal range or bilirubin >3 mg/dL), renal insufficiency (serum creatinine [Scr] >1.5 mg/dL), acute or life-threatening diseases (e.g., shock, collapse, stroke, coma of unknown etiology, or recent cardiac infarction), and pregnant or breast-feeding women

About this study

Official title: Insulin-like Growth Factor-1 as a Nutritional Monitoring Factor in Patients With Chronic Intestinal Failure

Nutrition support is critical to a vast number of patients who are hospitalized annually because of critical illnesses or surgery. It is also necessary for patients with chronic intestinal failure (CIF), who often require parenteral nutrition over periods of weeks or months. While scoring systems that assess nutritional risks in patients exist, there are no guidelines for continuous nutritional monitoring during supplementation and parenteral feeding. Previous studies have hinted that insulin-like growth factor-1 (IGF-1) may serve as a biomarker for nutritional support efficiency; however, such studies were not statistically definitive. Therefore, the investigators aimed to assess IGF-1 as a biomarker for both diagnosing nutritional risk and malnutrition and for monitoring the efficiency of nutritional support, particularly compared to other biomarkers such as BMI as well as albumin, prealbumin, transferrin, and retinol-binding protein.

Read the detailed description

Chronic intestinal failure (CIF) is one of the rarest of organ failures all over the world, mainly caused by severe gastrointestinal or systemic benign diseases such as intestinal fistula, short bowel, and mechanical obstruction. Moreover, patients with end-stage intra-abdominal or pelvic cancer can also develop into CIF. CIF is defined as gut function that is below the minimum necessary for the absorption of macronutrients and/or water and electrolytes; in such cases, nutrition support, especially for parenteral nutrition, is indispensable to maintain health and recovery for CIF patients.

Nutrition support has successfully saved the lives of thousands of patients with CIF, as well as those who have critical illnesses or underwent surgery. According to the guidelines, patients with CIF require parenteral nutrition over periods of weeks or months and the efficiency of nutrition support will influence the prognoses directly . The exact nutritional assessment and close nutritional monitoring are key points to optimize nutritional therapy. Firstly, the recommended scoring systems such as the Nutritional Risk Screening 2002 (NRS-2002) score or the 'nutrition risk in the critically ill' (NUTRIC) score can identify patients who are at nutritional risk and who would benefit from nutritional support. Secondly, nutritional support regimens should be individualized and adjusted over time based on continuous monitoring; however, there are no guidelines regarding such nutritional monitoring. The NRS-2002 and NUTRIC scores are recommended as initial nutritional assessment indices, but are inappropriate for continuous evaluation. Moreover, validated biomarkers that can be used for monitoring short-term nutritional status changes were still unclear. Nowadays, common serum protein markers such like albumin, prealbumin, transferrin, and retinol-binding protein (RBP) are used to monitor the efficiency of nutritional support in clinical practice [5, 8]. However, all these biomarkers failed to reflect changes of nutritional status with sufficient sensitivity in CIF patients.

Insulin-like growth factor-1 (IGF-1) is an IGF family member that consists of 70 amino acid residues. IGF-I was first reported as a nutritional marker in 1973 because its serum concentrations are reduced during malnutrition; its serum levels also proved to be affected by protein or/and energy deficiency. Several previous studies reported that IGF-1 is a more sensitive and specific indicator of nutritional status than prealbumin, transferrin, or RBP because of its shorter serum half-life and more accurate response to nutritional intake; however, these studies had small cohorts.

In present study, the investigators compared IGF-1 to traditional serum biomarkers in terms of diagnosing nutritional risk and malnutrition, as well as in monitoring the efficiency of nutrition support in CIF patients.

the investigators conducted a retrospective study of patients treated at a single clinical nutrition center of a tertiary referral hospital in China to investigate whether the measurement of IGF-1 is useful for monitoring the efficiency of nutritional support and to explore the relationship between IGF-1 and lean body mass in CIF patients. The influence of IGF-1 was also explored in this study. The data used were accumulated at the center between September 2013 and January 2017. All adult CIF patients (age ≥18 years) receiving nutrition support were included. The exclusion criteria were hepatic insufficiency (alanine transaminase/aspartate transaminase ratio 200% above normal range or bilirubin >3 mg/dL), renal insufficiency (serum creatinine [Scr] >1.5 mg/dL), acute or life-threatening diseases (e.g., shock, collapse, stroke, coma of unknown etiology, or recent cardiac infarction), and pregnant or breast-feeding women. The study was approved by the ethics committee of Jinling Hospital, Medical School of Nanjing University.

Malnutrition was defined as weight loss >10% within 6 months, a body mass index (BMI) <18.5, a subjective global assessment (SGA) score of stage C, or albumin level <30 g/L. Serum IGF-1, albumin, pre-albumin, transferrin, RBP, creatinine, and hemoglobin were measured weekly in patients receiving nutrition support after hospital admission. The resting energy expenditure, predicted weekly by indirect calorimetry (Quark PFT ERGO , COSMED Srl - Italy), was used to guide energy delivery. The target dose of protein intake was 1.2 g/kg/day, which was adjusted according to the level of serum albumin. Patients were also subjected to strict fluid intake management. The nutritional support schemes were recorded daily, and the body composition was also measured weekly to estimate nutrition status (Inbody S10, Biospace).

Keywords
Nutritional monitoring, insulin-like growth factor-1

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Nutrition indicators

    Insulin-like growth factor-1/Hemoglobin/albumin/prealbumin/transferrin/retinol binding protein/serum creatinine/cholesterol

    Measured: From date of patients enrollment until the date of patients discharge from hospital, assessed up to 2 months.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Sep 2017
  2. Study startSep 2013
  3. Primary completionJan 2017
  4. Study completionJan 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
197 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03277014
Sponsor's protocol ID
201502022-3
Status last verified
Sep 2017
First submitted
3 Sep 2017
Last updated
8 Sep 2017
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 1. Bielawska B, Allard JP. Nutrients 2017, 9(5). 2. Pironi L, Arends J, Bozzetti F, Cuerda C, Gillanders L, Jeppesen PB, Joly F, Kelly D, Lal S, Staun M et al. Clinical nutrition 2016, 35(2):247-307. 3. Pironi L. Best Pract Res Clin Gastroenterol 2016, 30(2):173-185. 4. Feinberg J, Nielsen EE, Korang SK, Halberg Engell K, Nielsen MS, Zhang K, Didriksen M, Lund L, Lindahl N, Hallum S et al. The Cochrane database of systematic reviews 2017, 5:Cd011598. 5. Taylor BE, McClave SA, Martindale RG, Warren MM, Johnson DR, Braunschweig C, McCarthy MS, Davanos E, Rice TW, Cresci GA et al. Crit Care Med 2016, 44(2):390-438. 6. McClave SA, DiBaise JK, Mullin GE, Martindale RG. Am J Gastroenterol 2016, 111(3):315-334.

  • Wang P, Yang J, Zhang Y, Zhang L, Gao X, Wang X. Risk Factors for Renal Impairment in Adult Patients With Short Bowel Syndrome. Front Nutr. 2021 Jan 18;7:618758. doi: 10.3389/fnut.2020.618758. eCollection 2020.

    PubMed 33537339
  • Wang X, Tian F, Sun H, Zhang L, Gao X, Huang Y, Yang J, Shen R, Wang J, Jiang T, Chen P, Liu S, Li J. Insulin-like growth factor-1 as a nutritional monitoring factor in patients with chronic intestinal failure. Clin Nutr. 2019 Aug;38(4):1737-1744. doi: 10.1016/j.clnu.2018.07.031. Epub 2018 Aug 2.

    PubMed 30126709

Questions about this trial

What is this clinical trial studying?

An observational study of Nutritional Supplement, run by Wang Xinying.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Nutrition indicators (time frame: From date of patients enrollment until the date of patients discharge from hospital, assessed up to 2 months.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03277014, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2017; AzTrials last refreshed its copy on 31 Oct 2026.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in