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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 12 December 2020
Main ID:  NCT03936829
Date of registration: 25/04/2019
Prospective Registration: Yes
Primary sponsor: Children's Hospital of Fudan University
Public title: Cyclophosphamide in the Treatment of Associated Acquired Lipodystrophy Syndrome With Type 1 Diabetes
Scientific title: Cyclophosphamide in the Treatment of Panniculitis Associated Acquired Lipodystrophy Syndrome With Type 1 Diabetes
Date of first enrolment: April 28, 2019
Target sample size: 10
Recruitment status: Recruiting
URL:  https://clinicaltrials.gov/show/NCT03936829
Study type:  Interventional
Study design:  Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).  
Phase:  N/A
Countries of recruitment
China
Contacts
Name:     Feihong Luo
Address: 
Telephone: +862164931226
Email: luofh@fudan.edu.cn
Affiliation: 
Name:     Feihong Luo
Address: 
Telephone: +862164931226
Email: luofh@fudan.edu.cn
Affiliation: 
Name:     Feihong Luo
Address: 
Telephone:
Email:
Affiliation:  Children's Hospital of Fudan University
Key inclusion & exclusion 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.



Age minimum: N/A
Age maximum: N/A
Gender: All
Health Condition(s) or Problem(s) studied
Lipodystrophy Acquired
Type1diabetes
Intervention(s)
Drug: Cyclophosphamide
Primary Outcome(s)
Average daily insulin dosage [Time Frame: week 21]
Secondary Outcome(s)
Average daily insulin dosage [Time Frame: from the completion of treatment to 12 months]
Average daily insulin dosage [Time Frame: from the completion of treatment to 3 months]
Average daily insulin dosage [Time Frame: from the completion of treatment to 6 months]
Average daily insulin dosage [Time Frame: from the completion of treatment to 9 months]
Average daily insulin dosage [Time Frame: week 1]
Average daily insulin dosage [Time Frame: week 13]
Average daily insulin dosage [Time Frame: week 17]
Average daily insulin dosage [Time Frame: week 5]
Average daily insulin dosage [Time Frame: week 9]
HbA1c level [Time Frame: from the completion of treatment to 12 months]
HbA1c level [Time Frame: from the completion of treatment to 3 months]
HbA1c level [Time Frame: from the completion of treatment to 6 months]
HbA1c level [Time Frame: from the completion of treatment to 9 months]
HbA1c level [Time Frame: week 1]
HbA1c level [Time Frame: week 13]
HbA1c level [Time Frame: week 17]
HbA1c level [Time Frame: week 21]
HbA1c level [Time Frame: week 5]
HbA1c level [Time Frame: week 9]
Secondary ID(s)
C-PAALS&T1D
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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