Nutritional SupplementNCT03277014
Using IGF-1 for Nutritional Monitoring
An observational study of Nutritional Supplement, run by Wang Xinying.
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).
- Conditions
- Nutritional Supplement
- 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.
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.
- First posted8 Sep 2017
- Study startSep 2013
- Primary completionJan 2017
- Study completionJan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Nutritional SupplementStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Wang Xinying
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Wang Xinying, Jinling Hospital, China
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 33537339Wang 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
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Insulin-like Growth Factor-1 as a Nutritional Monitoring Factor in Patients With Chronic Intestinal Failure
- ClinicalTrials.gov ID
- NCT03277014
- Acronym / sponsor ID
- 201502022-3
- Conditions
- Nutritional Supplement
- Keywords
- Nutritional monitoring, insulin-like growth factor-1
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 197 participants (actual)
- Lead sponsor
- Wang XinyingUniversity, hospital or other
- Study start
- Sep 2013 (actual)
- Primary completion
- Jan 2017 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 8 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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.
Key inclusion criteria (1 listed)
- All adult CIF patients (age ≥18 years) receiving nutrition support were included
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Nutrition indicators
Time frame: From date of patients enrollment until the date of patients discharge from hospital, assessed up to 2 months.
Insulin-like growth factor-1/Hemoglobin/albumin/prealbumin/transferrin/retinol binding protein/serum creatinine/cholesterol
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2017.
- Background1. 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.
- Derived from this study: PubMed 33537339Wang 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.
- Derived from this study: PubMed 30126709Wang 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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.