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

• Register: ClinicalTrials.gov
• Last refreshed on: 7 August 2023
• 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/ct2/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
• Affiliation: Children's Hospital of Fudan University

• Name: Feihong Luo

• Name: Feihong Luo

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

Type1diabetes

Lipodystrophy Acquired

Intervention(s)

Drug: Cyclophosphamide

Primary Outcome(s)

Average daily insulin dosage [Time Frame: week 21]

Secondary Outcome(s)

HbA1c level [Time Frame: from the completion of treatment to 6 months]

HbA1c level [Time Frame: week 21]

Average daily insulin dosage [Time Frame: week 13]

HbA1c level [Time Frame: week 13]

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 9 months]

Average daily insulin dosage [Time Frame: week 1]

Average daily insulin dosage [Time Frame: week 5]

HbA1c level [Time Frame: from the completion of treatment to 12 months]

HbA1c level [Time Frame: week 5]

Average daily insulin dosage [Time Frame: week 9]

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]

HbA1c level [Time Frame: from the completion of treatment to 9 months]

Average daily insulin dosage [Time Frame: week 17]

HbA1c level [Time Frame: from the completion of treatment to 3 months]

HbA1c level [Time Frame: week 1]

HbA1c level [Time Frame: week 9]

HbA1c level [Time Frame: week 17]

Secondary ID(s)

C-PAALS&T1D

Source(s) of Monetary Support

Please refer to primary and secondary sponsors