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Clinical trial

Cyclophosphamide in the Treatment of Panniculitis Associated Acquired Lipodystrophy Syndrome With Type 1 Diabetes

ID
Name
C-PAALS&T1D
Description
This study evaluates the change of insulin resistance and glucose metabolism of patients with panniculitis associated acquired lipodystrophy syndrome and type 1 diabetes with the treatment of cyclophosphamide.
Trial arms
Trial start
2019-04-28
Estimated PCD
2025-05-31
Trial end
2026-05-31
Status
Recruiting
Treatment
Cyclophosphamide
Admitted to the hospital every 4 weeks. Cyclophosphamide was intravenously instilled (500mg mg/m2 of BSA) after contraindications are excluded. ECG monitoring will be taken during the medication. A total of 6 treatments will be performed.
Arms:
Interventional
Other names:
CYC
Size
10
Primary endpoint
Average daily insulin dosage
week 21
Eligibility criteria
Inclusion Criteria: 1. Meet the diagnostic criteria of type 1 diabetes mellitus: clinical manifestations of typical diabetes mellitus include polyphagia, polyuria, weight loss, or diabetic ketoacidosis, confirmed by blood sugar level, islet function and autoimmune antibody. 2. Meet the diagnostic criteria for panniculitis: fat biopsy suggests inflammatory infiltration. 3. Meet the diagnostic criteria for acquired lipodystrophy syndrome: childhood onset, clinically no nutritional deficiency or catabolism, systemic or partial subcutaneous fat reduction, genetic testing to exclude congenital lipodystrophy syndrome; low leptin level and autoantibodies can aid in diagnosis. Exclusion Criteria: 1. Mature and effective treatment methods are available. 2. HIV, HBV and HCV were positive. 3. A the active period of infection. 4. At the active stage of malignant tumors. 5. Combination of other fatal diseases. 6. Existence of mental and psychological diseases.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 10, 'type': 'ESTIMATED'}}
Updated at
2023-08-01

1 organization

1 drug

2 indications

Organization
Children's Hospital of Fudan University
Drug
cyclophosphamide
Indication
Acquired Lipodystrophy
Indication
Type 1 diabetes