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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03936829
Recruitment Status : Recruiting
First Posted : May 3, 2019
Last Update Posted : February 27, 2020
Sponsor:
Information provided by (Responsible Party):
Children's Hospital of Fudan University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Lipodystrophy Acquired Type1diabetes Drug: Cyclophosphamide Not Applicable

Detailed Description:

Patients with panniculitis associated acquired lipodystrophy syndrome and type 1 diabetes have difficulty in blood glucose management due to the presence of both severe insulin resistance and complete insulin deficiency. It is often necessary to use insulin doses several times that of other children of the same age with type 1 diabetes.

Since autoimmune response is the main cause of panniculitis associated acquired lipodystrophy syndrome, immunosuppressive agents can suppress immune response, prevent and alleviate the progression of panniculitis and acquired lipodystrophy syndrome, and improve insulin resistance caused by subcutaneous fat deficiency.

Cyclophosphamide is a classic immunosuppressive agent. This study hopes to improve insulin resistance of patients with panniculitis associated acquired lipodystrophy syndrome and type 1 diabetes by cyclophosphamide treatment, thereby reducing insulin dosage and improving glucose metabolism.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Cyclophosphamide in the Treatment of Panniculitis Associated Acquired Lipodystrophy Syndrome With Type 1 Diabetes
Actual Study Start Date : April 28, 2019
Estimated Primary Completion Date : May 31, 2021
Estimated Study Completion Date : May 31, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

Arm Intervention/treatment
Experimental: Interventional
Drug:Cyclophosphamide Dosage form: intravenous infusion Dosage: 500 mg/m2 of BSA Frequency: every 4 weeks Duration: 24 weeks
Drug: 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.
Other Name: CYC




Primary Outcome Measures :
  1. Average daily insulin dosage [ Time Frame: week 21 ]
    Average daily insulin dosage of continuous three days (the average of the 1st, 2nd and 3rd days' insulin requirements after the last cyclophosphamide treatment, the blood glucose meets the ISPAD guideline as premeal 4.0-7.0 mmol/L, postmeal 5.0-10.0 mmol/L, prebed 4.4-7.8 mmol/L)


Secondary Outcome Measures :
  1. Average daily insulin dosage [ Time Frame: week 1 ]
    Average daily insulin dosage of continuous three days (the average of the 1st, 2nd and 3rd days' insulin requirements after the first cyclophosphamidethe, blood glucose meets the ISPAD guideline as premeal 4.0-7.0 mmol/L, postmeal 5.0-10.0 mmol/L, prebed 4.4-7.8 mmol/L)

  2. Average daily insulin dosage [ Time Frame: week 5 ]
    Average daily insulin dosage of continuous three days (the average of the 1st, 2nd and 3rd days' insulin requirements after the 2nd cyclophosphamide, the blood glucose meets the ISPAD guideline as premeal 4.0-7.0 mmol/L, postmeal 5.0-10.0 mmol/L, prebed 4.4-7.8 mmol/L)

  3. Average daily insulin dosage [ Time Frame: week 9 ]
    Average daily insulin dosage of continuous three days (the average of the 1st, 2nd and 3rd days' insulin requirements after the 3rd cyclophosphamide, the blood glucose meets the ISPAD guideline as premeal 4.0-7.0 mmol/L, postmeal 5.0-10.0 mmol/L, prebed 4.4-7.8 mmol/L)

  4. Average daily insulin dosage [ Time Frame: week 13 ]
    Average daily insulin dosage of continuous three days (the average of the 1st, 2nd and 3rd days' insulin requirements after the 4th cyclophosphamide, the blood glucose meets the ISPAD guideline as premeal 4.0-7.0 mmol/L, postmeal 5.0-10.0 mmol/L, prebed 4.4-7.8 mmol/L)

  5. Average daily insulin dosage [ Time Frame: week 17 ]
    Average daily insulin dosage of continuous three days (the average of the 1st, 2nd and 3rd days' insulin requirements after the 5th cyclophosphamide, the blood glucose meets the ISPAD guideline as premeal 4.0-7.0 mmol/L, postmeal 5.0-10.0 mmol/L, prebed 4.4-7.8 mmol/L)

  6. Average daily insulin dosage [ Time Frame: from the completion of treatment to 3 months ]
    Average daily insulin dosage of continuous three days (the average of 3 days' insulin requirements 3 months after the last cyclophosphamide treatment, the blood glucose meets the ISPAD guideline as premeal 4.0-7.0 mmol/L, postmeal 5.0-10.0 mmol/L, prebed 4.4-7.8 mmol/L)

  7. Average daily insulin dosage [ Time Frame: from the completion of treatment to 6 months ]
    Average daily insulin dosage of continuous three days (the average of 3 days' insulin requirements 6 months after the last cyclophosphamide treatment, the blood glucose meets the ISPAD guideline as premeal 4.0-7.0 mmol/L, postmeal 5.0-10.0 mmol/L, prebed 4.4-7.8 mmol/L)

  8. Average daily insulin dosage [ Time Frame: from the completion of treatment to 9 months ]
    Average daily insulin dosage of continuous three days (the average of 3 days' insulin requirements 9 months after the last cyclophosphamide treatment, the blood glucose meets the ISPAD guideline as premeal 4.0-7.0 mmol/L, postmeal 5.0-10.0 mmol/L, prebed 4.4-7.8 mmol/L)

  9. Average daily insulin dosage [ Time Frame: from the completion of treatment to 12 months ]
    Average daily insulin dosage of continuous three days (the average of 3 days' insulin requirements 12 months after the last cyclophosphamide treatment, the blood glucose meets the ISPAD guideline as premeal 4.0-7.0 mmol/L, postmeal 5.0-10.0 mmol/L, prebed 4.4-7.8 mmol/L)

  10. HbA1c level [ Time Frame: week 1 ]
    HbA1c level

  11. HbA1c level [ Time Frame: week 5 ]
    HbA1c level

  12. HbA1c level [ Time Frame: week 9 ]
    HbA1c level

  13. HbA1c level [ Time Frame: week 13 ]
    HbA1c level

  14. HbA1c level [ Time Frame: week 17 ]
    HbA1c level

  15. HbA1c level [ Time Frame: week 21 ]
    HbA1c level

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

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

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

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



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

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): NCT03936829


Contacts
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Contact: Feihong Luo +862164931226 ext +862164931226 luofh@fudan.edu.cn
Contact: Zhenran H Xu +862164931226 ext +862164931226 xu_zhenran@163.com

Locations
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China, Shanghai
Children's Hospital of Fudan University Recruiting
Shanghai, Shanghai, China
Contact: Feihong Luo    +862164931226 ext +862164931226    luofh@fudan.edu.cn   
Contact: Zhenran Xu    +862164931226 ext +862164931226    xu_zhenran@163.com   
Sponsors and Collaborators
Children's Hospital of Fudan University
Investigators
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Study Chair: Feihong Luo Children's Hospital of Fudan University
  Study Documents (Full-Text)

Documents provided by Children's Hospital of Fudan University:
Study Protocol  [PDF] April 9, 2019
Statistical Analysis Plan  [PDF] April 9, 2019
Informed Consent Form  [PDF] April 9, 2019

Publications:

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Responsible Party: Children's Hospital of Fudan University
ClinicalTrials.gov Identifier: NCT03936829    
Other Study ID Numbers: C-PAALS&T1D
First Posted: May 3, 2019    Key Record Dates
Last Update Posted: February 27, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Children's Hospital of Fudan University:
panniculitis associated acquired generalised lipodystrophy
cyclophosphamide
Additional relevant MeSH terms:
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Lipodystrophy
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Skin Diseases, Metabolic
Skin Diseases
Lipid Metabolism Disorders
Cyclophosphamide
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists