UnknownNot Applicable

Effect of Nocturnal Parenteral Nutrition on Bone Turnover and Energy Metabolism

Netherlands20 participantsStarted 2023-07-13

Plain-language summary

This clinical trial will study the effect of daytime versus nighttime parenteral nutrition on bone turnover, glucose variability, nitrogen balance, sleep and wake rhythm and peripheral clock gene expression in patients with chronic intestinal failure.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Home parenteral nutrition for at least 5 nights a week * On home parenteral nutrition for more than 1 year * No major changes in parenteral nutrition for 3 months prior to inclusion Exclusion Criteria: * Parenteral infusion for more than 16 h a day * Use of bone modifying drugs in the last 2 years * Bone fractures in the past year * Renal insufficiency (eGFR \< 60 ml/min) * HbA1c ≥48 mmol/ml * Use of corticosteroids * Shift work * Performing intensive exercise (\> 2 hours a day and \> 3 times a week)

What they're measuring

Differences in bone turnover marker Procollagen 1 Intact N-Terminal Propeptide

Timeframe: Study day 1 versus study day 2

Differences in bone turnover marker carboxy-terminal collagen crosslinks

Timeframe: Study day 1 versus study day 2

Changes in glucose variability

Timeframe: 2 weeks versus 2 weeks

Trial details

NCT IDNCT05868785

SponsorAcademisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-11

Contact for this trial

M.J.M. Serlie, professor

+31205669111 m.j.m.serlie@amsterdamumc.nl

View on ClinicalTrials.gov More Intestinal Failure trials