Inflammatory Bowel DiseaseCEDERN-1NCT02275676
Resting Energy Expenditure and Nutritional Status in IBD
An observational study of Inflammatory Bowel Disease and Malnutrition, run by University Hospital Muenster at 1 site in Germany.
Trial summary
Nutrient deficiencies occur frequently in IBD patients. The absorption rate of nutrients in IBD is often limited by chronic inflammation, but is also commonly reduced by missing intestinal segments due to previous operations. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Inflammatory Bowel Disease, Malnutrition
- What is being tested?
- bioelectrical impedance analysis and indirect calorimetry
- How many people
- 200 participants
- Where
- 1 siteGermany
- Study dates
- Sep 2014to Sep 2016
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with active or inactive inflammatory bowel disease at our medical tertiary referral center, Muenster Germany
Who may be able to join
- inflammatory bowel disease
- male and female between 18-80 years
- patient fully able to understand the study concept and to give his or her written consent
Who cannot join
- underlying malignant disease
- Diabetes mellitus, Type I or II
- Pregnancy
- Lactating
- chronic alcohol or drug abuse
- known anorexia nervosa or binge eating disorder
Show all 9Show fewer
- known metabolic disorders, such as e.g. Cushing disease, hypothyroidism
- Participation in other interventional studies within the last 6 months prior to study enrollment
- patient not fully able to understand the study concept and to give his or her written consent
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
University Hospital Muenster
Münster, 48149
Frank Lenze, Dr.
Hauke Heinzow, Dr.
About this study
Official title: Influence of Disease Activity of Inflammatory Bowel Disease on Resting Energy Expenditure and Nutritional Status
Nutrient deficiencies occur frequently in IBD patients. The absorption rate of nutrients in IBD is often limited by chronic inflammation, but is also commonly reduced by missing intestinal segments due to previous operations. Patients are predominantly affected by malnutrition, which is often resembled by weight loss, specific micronutrient deficits such as iron deficiency, vitamin B12 deficiency, folic acid deficiency, vitamin D deficiency and zinc depletion. The etiology of nutritional problems is multifactorial and not exclusively limited to active phases of the disease. Causes of malnutrition can be inadequate food intake, maldigestion, malabsorption or increased nutritional requirement. Malnutrition itself is associated with a delayed recovery of impaired wound healing, reduced quality of life and longer hospital stays. Therefore, observation and modification of the nutritional status should be an integral part of therapy in IBD patients.
The primary objective of our study is to investigate the influence of the disease on the resting energy expenditure and nutritional status during acute inflammation and clinical remission of the disease. Secondary objectives are to assess possible nutritional deficiencies. On the other hand it is well known that patients with IBD are at increased risk for coronary heart disease. Therefore, another secondary focus of our observational study is whether the composition of the HDL proteins is changed towards pro-atherogenic HDL-proteins and whether possible changes occur in patients in clinical remission or with active disease.
Read the detailed description
Primary objective of the study is to investigate the influence of the disease activity on the resting energy expenditure and the nutritional status in patients with chronic inflammatory bowel disease (IBD). The impact of IBD on the nutritional status and the resting energy expenditure is currently not fully understood. IBD includes two different disease entities, Crohn's disease and ulcerative colitis. Both are characterized by diarrhea, loss of weight, rectal bleeding and abdominal discomfort (abdominal pain, flatulence). In patients with IBD malabsorption, one-sided nutritional behavior, food abandonment, malnutrition, nutrient deficiency and weight loss are common issues. Malnutrition is associated with delayed recovery, impaired wound healing, reduced quality of life and prolonged hospital stay. The malnutrition is not limited to active disease state. Rates for malnutrition in patients with Crohn's disease range from 20 - 85%. Hence, the assessment of the nutritional status is important in the treatment of patients with IBD. Different methods are used to assess the impact of the disease activity on the nutritional status. To investigate the resting energy expenditure the well evaluated indirect calorimetry is used. The principle of the measurement is based on determination of the oxygen absorption during inspiration and the simultaneous determination of the release of carbon dioxide during expiration. The use of bioelectrical impedance analysis (BIA) is a widespread measurement to assess the composition of the body. BIA allows the determination of the fat-free mass, total body water, body cell mass, fat mass and extracellular mass.
Both measurements are non-invasive and reproducible. Additionally different blood parameters are determined such as HDL-subgroups, vitamin b12, folic acid, vitamin K, vitamin D, 25-hydroxy-vitamin D3, zinc, ferritin, albumin, citrulline and routine laboratory (blood count, serum chemistry, coagulation) . Moreover the quality of life is measured through a suitable questionnaire (Gastrointestinal Life Quality Index) as well as the subjective global assessment to estimate the nutritional status.
Furthermore, a secondary aim of the study is to investigate the correlation of HDL-subgroups and the severity of the IBD activity. High-Density-Lipoproteins are a heterogeneous group of lipoproteins with both anti-atherogenic and multiple anti-inflammatory properties. Recent research showed that the quality of HDL-particle is even more important than the quantity. It could be shown that changes in the composition of the HDL could cause an inflammatory status and thus affect the activity of chronic inflammatory disease. Therefore, it is the aim of the study to investigate if changes in the composition of HDL-proteins towards pro-atherogenic HDL-proteins exist.
The study will take place at the University Hospital of Muenster, Germany. Patients who are suitable for participating in the study will be measured and counseled during their regular out-clinic visits. Each patient has to undergo the procedure while they are in an active state of the disease and during remission. It is expected to include 200 patients over 2 years.
- Conditions
- Inflammatory Bowel Disease, Malnutrition
- Being tested
- bioelectrical impedance analysis, indirect calorimetry
- Keywords
- Inflammatory bowel disease, Nutritional Status, Malnutrition, Resting Energy Expenditure
- Medical subject headings
- Inflammatory Bowel Diseases, Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bioelectrical impedance analysisOther
indirect calorimetryOther
| Study group | Role | What they receive |
|---|---|---|
| Inflammatory bowel disease | Patients with active and inactive inflammatory bowel disease Receives: Other: bioelectrical impedance analysis; Other: indirect calorimetry |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in bioelectrical impedance analysis (BIA)
e.g. fat free mass, total body water, body cell mass
Measured: change from baseline in BIA at 6 month and at 12 month
Change in resting energy expenditure (REE)
Resting energy expenditure measured by indirect calorimetry (kcal per day)
Measured: change from baseline in REE at 6 month and at 12 month
Secondary outcomes (3)
change in HDL subgroup analysis
Measured: day 1, every 6 month up to 12 month
change in plasma citrulline level
Measured: day 1, every 6 month up to 12 month
change in plasma vitamine levels and plasma zinc level
Vitamin B12, Vitamin K, Vitamin D
Measured: day 1, every 6 month up to 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2014 (estimated)
- Study startSep 2014
- Primary completionSep 2016 (estimated)
- Study completionSep 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory Bowel DiseaseStudies 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
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Muenster
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. med. Hauke Heinzow, University Hospital Muenster
- Investigators
- Frank Lenze, Dr., Principal investigator, University Hospital Muenster, GermanyHauke Heinzow, Dr., Principal investigator, University Hospital Muenster, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02275676
- Sponsor's protocol ID
- CEDERN1
- Acronym
- CEDERN-1
- Status last verified
- Oct 2014
- First submitted
- 13 Oct 2014
- Last updated
- 27 Oct 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Disease Activity of Inflammatory Bowel Disease on Resting Energy Expenditure and Nutritional Status
- ClinicalTrials.gov ID
- NCT02275676
- Acronym / sponsor ID
- CEDERN-1 / CEDERN1
- Conditions
- Inflammatory Bowel Disease, Malnutrition
- Keywords
- Inflammatory bowel disease, Nutritional Status, Malnutrition, Resting Energy Expenditure
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University Hospital MuensterUniversity, hospital or other
- Study start
- Sep 2014
- Primary completion
- Sep 2016 (estimated)
- Study completion
- Sep 2016 (estimated)
- First posted
- 27 Oct 2014 (estimated)
- 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.
Nutrient deficiencies occur frequently in IBD patients. The absorption rate of nutrients in IBD is often limited by chronic inflammation, but is also commonly reduced by missing intestinal segments due to previous operations. Patients are predominantly affected by malnutrition, which is often resembled by weight loss, specific micronutrient deficits such as iron deficiency, vitamin B12 deficiency, folic acid deficiency, vitamin D deficiency and zinc depletion. The etiology of nutritional problems is multifactorial and not exclusively limited to active phases of the disease. Causes of malnutrition can be inadequate food intake, maldigestion, malabsorption or increased nutritional requirement. Malnutrition itself is associated with a delayed recovery of impaired wound healing, reduced quality of life and longer hospital stays. Therefore, observation and modification of the nutritional status should be an integral part of therapy in IBD patients.
The primary objective of our study is to investigate the influence of the disease on the resting energy expenditure and nutritional status during acute inflammation and clinical remission of the disease. Secondary objectives are to assess possible nutritional deficiencies. On the other hand it is well known that patients with IBD are at increased risk for coronary heart disease. Therefore, another secondary focus of our observational study is whether the composition of the HDL proteins is changed towards pro-atherogenic HDL-proteins and whether possible changes occur in patients in clinical remission or with active disease.
Detailed description
Primary objective of the study is to investigate the influence of the disease activity on the resting energy expenditure and the nutritional status in patients with chronic inflammatory bowel disease (IBD). The impact of IBD on the nutritional status and the resting energy expenditure is currently not fully understood. IBD includes two different disease entities, Crohn's disease and ulcerative colitis. Both are characterized by diarrhea, loss of weight, rectal bleeding and abdominal discomfort (abdominal pain, flatulence). In patients with IBD malabsorption, one-sided nutritional behavior, food abandonment, malnutrition, nutrient deficiency and weight loss are common issues. Malnutrition is associated with delayed recovery, impaired wound healing, reduced quality of life and prolonged hospital stay. The malnutrition is not limited to active disease state. Rates for malnutrition in patients with Crohn's disease range from 20 - 85%. Hence, the assessment of the nutritional status is important in the treatment of patients with IBD. Different methods are used to assess the impact of the disease activity on the nutritional status. To investigate the resting energy expenditure the well evaluated indirect calorimetry is used. The principle of the measurement is based on determination of the oxygen absorption during inspiration and the simultaneous determination of the release of carbon dioxide during expiration. The use of bioelectrical impedance analysis (BIA) is a widespread measurement to assess the composition of the body. BIA allows the determination of the fat-free mass, total body water, body cell mass, fat mass and extracellular mass.
Both measurements are non-invasive and reproducible. Additionally different blood parameters are determined such as HDL-subgroups, vitamin b12, folic acid, vitamin K, vitamin D, 25-hydroxy-vitamin D3, zinc, ferritin, albumin, citrulline and routine laboratory (blood count, serum chemistry, coagulation) . Moreover the quality of life is measured through a suitable questionnaire (Gastrointestinal Life Quality Index) as well as the subjective global assessment to estimate the nutritional status.
Furthermore, a secondary aim of the study is to investigate the correlation of HDL-subgroups and the severity of the IBD activity. High-Density-Lipoproteins are a heterogeneous group of lipoproteins with both anti-atherogenic and multiple anti-inflammatory properties. Recent research showed that the quality of HDL-particle is even more important than the quantity. It could be shown that changes in the composition of the HDL could cause an inflammatory status and thus affect the activity of chronic inflammatory disease. Therefore, it is the aim of the study to investigate if changes in the composition of HDL-proteins towards pro-atherogenic HDL-proteins exist.
The study will take place at the University Hospital of Muenster, Germany. Patients who are suitable for participating in the study will be measured and counseled during their regular out-clinic visits. Each patient has to undergo the procedure while they are in an active state of the disease and during remission. It is expected to include 200 patients over 2 years.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Inflammatory bowel disease | – | Other: bioelectrical impedance analysis, Other: indirect calorimetryPatients with active and inactive inflammatory bowel disease |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with active or inactive inflammatory bowel disease at our medical tertiary referral center, Muenster Germany
Key inclusion criteria (3 listed)
- inflammatory bowel disease
- male and female between 18-80 years
- patient fully able to understand the study concept and to give his or her written consent
Key exclusion criteria (9 listed)
- underlying malignant disease
- Diabetes mellitus, Type I or II
- Pregnancy
- Lactating
- chronic alcohol or drug abuse
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| bioelectrical impedance analysis | Other | Inflammatory bowel disease |
| indirect calorimetry | Other | Inflammatory bowel disease |
Primary outcome
change in bioelectrical impedance analysis (BIA)
Time frame: change from baseline in BIA at 6 month and at 12 month
e.g. fat free mass, total body water, body cell mass
Change in resting energy expenditure (REE)
Time frame: change from baseline in REE at 6 month and at 12 month
Resting energy expenditure measured by indirect calorimetry (kcal per day)
3 secondary outcomes
change in HDL subgroup analysis
Time frame: day 1, every 6 month up to 12 month
change in plasma citrulline level
Time frame: day 1, every 6 month up to 12 month
change in plasma vitamine levels and plasma zinc level
Time frame: day 1, every 6 month up to 12 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2014.
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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.
Frank Lenze, Dr. principal investigator
University Hospital Muenster, Germany
Hauke Heinzow, Dr. principal investigator
University Hospital Muenster, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Inflammatory Bowel Disease and Malnutrition, run by University Hospital Muenster at 1 site in Germany.
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 3 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 27 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Frank Lenze, Dr. (+49-251-8358103, frank.lenze@ukmuenster.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in bioelectrical impedance analysis (BIA) (time frame: change from baseline in BIA at 6 month and at 12 month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Oct 2014.