Dental Health, Diet, Inflammation and Biomarkers in Patients With Acute Intermittent Porphyria(AIP)
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|ClinicalTrials.gov Identifier: NCT01617642|
Recruitment Status : Not yet recruiting
First Posted : June 12, 2012
Last Update Posted : June 12, 2012
|Condition or disease|
|Acute Intermittent Porphyria|
In a group of people with proven acute intermittent porphyria (AIP) mutation, some will remain asymptomatic, while others have repeated periods of porphyria symptoms. Glucose inhibits ALA synthetase (ALAS), the first rate-limiting enzyme in the haem synthesis. Studies of individual patients point to the fact that increased glucose and/or fructose content in the diet inhibits porphyria attacks. A high sugar intake can reduce the disease activity in patients with AIP. The diet and related biomarkers of those with latent and manifest AIP will therefore be mapped to explain why some have latent and others have manifest acute intermittent porphyria. Other studies point to the fact that people with manifest AIP who have later developed diabetes type 2 no longer have porphyria symptoms. Dental health will also be examined.
Inflammation also affects the haem synthesis. Infections and/or inflammation are known to trigger AIP attacks. The disease activity in patients with acute intermittent porphyria in relation to inflammatory status, iron status, glucose metabolism and diet will therefore be examined.
The iron metabolism is interesting to study because it is believed that the overstimulation of the haem synthesis is what triggers porphyria attacks. Haem consists of iron and protoporphyrin IX, and it is therefore possible that iron supplements in cases of iron deficiency can induce increased haem synthesis and by doing so trigger and/or aggravate AIP.
Kidney failure is a serious secondary complication in some patients with MAIP. Protein markers for kidney injury in urine will be examined.
|Study Type :||Observational|
|Estimated Enrollment :||150 participants|
|Observational Model:||Case Control|
|Official Title:||Dental Health, Diet, Inflammation and Biomarkers in Patients With Acute Intermittent Porphyria(AIP)|
|Study Start Date :||July 2012|
|Estimated Primary Completion Date :||August 2017|
|Estimated Study Completion Date :||December 2021|
Healthy control group, matched for age and gender
Acute intermittent porphyria
Patients with acute intermittent porphyria.
- Blood pressure [ Time Frame: Within 2 months after inclusion ]Resting systolic and diastolic blood pressure, a number of inflammatory parameters, serum markers for iron status and inflammation
- Diet registration [ Time Frame: Within 2 months after inclusion ]Dietary registration during one week
- Iron status [ Time Frame: Within 2 months after inclusion ]Blood samples for evaluation of iron status
- Inflammatory status [ Time Frame: Within 2 months after inclusion ]Blood samples (cytokines etc) for evaluation of inflammation
- Dental health [ Time Frame: Within two months after inclusion ]Evaluate dental health through clinical examination
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01617642
|Contact: Ole L Brekke, MD, PhD||+47 firstname.lastname@example.org|
|Contact: Elin Storjord, MDemail@example.com|
|Nordlandssykehuset HF||Not yet recruiting|
|Bodø, Nordland, Norway, N-8092|
|Contact: Ole L Brekke, MD, PhD +47 75578365 firstname.lastname@example.org|
|Principal Investigator: Ole L Brekke, MD, PhD|
|Sub-Investigator: Elin Storjord, MD|
|Sub-Investigator: Tom E Mollnes, MD, PhD|
|Principal Investigator:||Ole L Brekke, MD, PhD||University of Tromsø, Norway|