Resting Energy Expenditure and Nutritional Status in IBD

NCT02275676 | Unknown

• 1 other identifier: CEDERN1
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Inflammatory Bowel Disease; Malnutrition

Keywords

Inflammatory bowel disease; Nutritional Status; Malnutrition; Resting Energy Expenditure

Outcome Measures

Primary Outcomes (2)

• change in bioelectrical impedance analysis (BIA)

  e.g. fat free mass, total body water, body cell mass

  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)

  change from baseline in REE at 6 month and at 12 month

Secondary Outcomes (3)

• change in HDL subgroup analysis

  day 1, every 6 month up to 12 month

• change in plasma citrulline level

  day 1, every 6 month up to 12 month

• change in plasma vitamine levels and plasma zinc level

  day 1, every 6 month up to 12 month

Other Outcomes (2)

• change in fecal Calprotectin level

  day 1, every 6 month up to 12 month

• change in live quality questionnaire

  day 1, every 6 month up to 12 month

Study Arms (1)

Inflammatory bowel disease

Patients with active and inactive inflammatory bowel disease

Other: bioelectrical impedance analysis; Other: indirect calorimetry

Interventions

bioelectrical impedance analysis OTHER

Inflammatory bowel disease

indirect calorimetry OTHER

Inflammatory bowel disease

Eligibility Criteria

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

Study Population

Patients with active or inactive inflammatory bowel disease at our medical tertiary referral center, Muenster Germany

You may qualify if:

• 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

You may not qualify if:

• underlying malignant disease
• Diabetes mellitus, Type I or II
• Pregnancy
• Lactating
• chronic alcohol or drug abuse
• known anorexia nervosa or binge eating disorder
• 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

Sponsors & Collaborators

• University Hospital Muenster: lead

Study Sites (1)

University Hospital Muenster

Münster, 48149, Germany

RECRUITING

MeSH Terms

Conditions

Inflammatory Bowel Diseases; Malnutrition

Interventions

Calorimetry, Indirect

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Nutrition Disorders; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Calorimetry; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Frank Lenze, Dr.

  University Hospital Muenster, Germany

  PRINCIPAL INVESTIGATOR

• Hauke Heinzow, Dr.

  University Hospital Muenster, Germany

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Frank Lenze, Dr.

CONTACT

+49-251-8358103; frank.lenze@ukmuenster.de

Hauke Heinzow, Dr.

CONTACT

+49-251-8347661; hauke.heinzow@ukmuenster.de

Study Design

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

Study Record Dates

• First Submitted: October 13, 2014
• First Posted: October 27, 2014
• Study Start: September 1, 2014
• Primary Completion: September 1, 2016
• Study Completion: September 1, 2016
• Last Updated: October 27, 2014

Record last verified: 2014-10

Locations

DE (1)