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

Course and regulators of phosphate metabolism in diabetic ketoacidosis in type 1 diabetes: a prospective study - Phosphate metabolism in DKA (DKA-Pi)

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON50204
Enrollment
13
Registered
2021-11-24
Start date
2022-04-04
Completion date
Unknown
Last updated
2024-08-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

acidosis diabetic ketoacidosis

Interventions

None listed

Sponsors

Universitair Medisch Centrum Groningen
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
Primary outcome is the association between FGF23 and phosphate during treatment for DKA corrected for follow-up time. Time course analyses will be performed to gain insight in the sequence of events and potential causal relationships. Furthermore, consequences of hypophosphatemia in cellular energy state will be addressed.

Secondary

MeasureTime frame
Secondary outcomes include markers of oxidative stress, mitochondrial dysfunction and cellular senescence.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)