The effect of parenteral nutrition during nighttime versus daytime on bone turnover and energy metabolism in intestinal failure patients.

Recruiting

• Conditions: 10018424; Circadian synchronisation; sleep - wake rhythm, nitrogen balance and clock gene expression; energy metabolism; 10013296

• Registration Number: NL-OMON51527
• Lead Sponsor: Academisch Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 20

Inclusion Criteria

Chronic intestinal failure
Parenteral nutrition for at least 3 nights a week
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 < 30 ml/min)
HbA1c >=53 mmol/ml
Use of corticosteroids (systemic, cutaneous >5cm2 or WHO class I-III)
Shift work
Performing intensive exercise (> 2 hours a day and > 3 times a week)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Differences in the bone turnover markers serum P1NP and CTX-1, changes in<br /><br>glucose variability measured by a continuous glucose monitor and changes in<br /><br>insulin levels.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Differences in nitrogen balance, sleep/wake rhythm, clock gene expression,<br /><br>resting energy expenditure and substrate oxidation rates, body temperature</p><br>