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Course and regulators of phosphate metabolism in diabetic ketoacidosis in type 1 diabetes: a prospective study

Completed
Conditions
acidosis
diabetic ketoacidosis
10012653
Registration Number
NL-OMON50204
Lead Sponsor
niversitair Medisch Centrum Groningen
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
Not specified
Target Recruitment
13
Inclusion Criteria

- Age 18 to 75 years
- T1DM, diagnosed prior to admission (the T1DM diagnosis should be based upon
the presence of (i) hyperglycemia (fasting glucose levels >7.0 mmol/L or random
glucose levels >11.1 mmol/L), (ii) c-peptide levels of less than 0.2 nmol/L and
(iii) presence of auto-immunity (anti-GAD, anti-islet auto-antibodies and/or
zinc receptors))
- DKA defined as
• Blood glucose levels >15mmol/L
• Presence of urine ketones
• pH levels <7.30 kPa
- Dutch writing and speaking proficiency
- Ability to provide oral and written informed consent.
- Included in Acutelines, where blood sample was drawn upon ED admission

Exclusion Criteria

- Pregnancy (actual or planned)
- Known underlying condition in which phosphate metabolism is altered,
including hyperparathyroidism, vitamin D deficiency, Fanconi syndrome,
chronic diarrhoea, and use of medication with hypophosphatemia as a
side-effect, such a
pamidronic acid or ferric carboxymaltose
- Inability or unwillingness to meet the protocol requirements
- Any severe or uncontrolled medical or psychological condition which, in the
opinion of the investigator, would compromise the ability to meet protocol
requirements

Study & Design

Study Type
Observational invasive
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
<p>Primary outcome is the association between FGF23 and phosphate during treatment<br /><br>for DKA corrected for follow-up time. Time course analyses will be performed to<br /><br>gain insight in the sequence of events and potential causal relationships.<br /><br>Furthermore, consequences of hypophosphatemia in cellular energy state will be<br /><br>addressed. </p><br>
Secondary Outcome Measures
NameTimeMethod
<p>Secondary outcomes include markers of oxidative stress, mitochondrial<br /><br>dysfunction and cellular senescence. </p><br>
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