Autologous Stem Cell and Hyperbaric Oxygen Therapy in Type 2 Diabetes Mellitus (HOT)

This study has been completed.
Sponsor:
Collaborator:
University of Miami
Information provided by (Responsible Party):
Rodolfo Alejandro, University of Miami
ClinicalTrials.gov Identifier:
NCT01786707
First received: February 5, 2013
Last updated: March 18, 2014
Last verified: March 2014
Results First Received: December 20, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Prevention
Condition: Type 2 Diabetes Mellitus
Intervention: Biological: Autologous stem cells and hyperbaric oxygen therapy

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Autologous SC and HOT

Autologous stem cells and hyperbaric oxygen therapy

Autologous stem cells and hyperbaric oxygen therapy: Subjects will receive standard medical treatment (SMT) with insulin and metformin for 4 months. Then they will be randomized to either control or intervention groups. HOT and SC group: combination of HOT therapy and intrapancreatic autologous SC infusion in addition to SMT.

Control Group Patients in a control group will continue with standard medical treatment (SMT)

Participant Flow:   Overall Study
    Autologous SC and HOT     Control Group  
STARTED     1     1  
COMPLETED     0     0  
NOT COMPLETED     1     1  
Lost to Follow-up                 1                 1  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Autologous SC and HOT

Autologous stem cells and hyperbaric oxygen therapy

Autologous stem cells and hyperbaric oxygen therapy: Subjects will receive standard medical treatment (SMT) with insulin and metformin for 4 months. Then they will be randomized to either control or intervention groups. HOT and SC group: combination of HOT therapy and intrapancreatic autologous SC infusion in addition to SMT.

Control Group Patients in a control group will continue with standard medical treatment (SMT)
Total Total of all reporting groups

Baseline Measures
    Autologous SC and HOT     Control Group     Total  
Number of Participants  
[units: participants]
  1     1     2  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     1     1     2  
>=65 years     0     0     0  
Gender  
[units: participants]
     
Female     0     1     1  
Male     1     0     1  



  Outcome Measures

1.  Primary:   The Reduction in HbA1c From Time of Randomization to 1 Year After Intervention.   [ Time Frame: 1 year ]

2.  Secondary:   The Proportion of Subjects With a Reduction of >1% in HbA1c   [ Time Frame: at 6 months ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Rodolfo Alejandro
Organization: University of Miami School of Medicine
phone: 3052435324
e-mail: ralejand@med.miami.edu


No publications provided


Responsible Party: Rodolfo Alejandro, University of Miami
ClinicalTrials.gov Identifier: NCT01786707     History of Changes
Other Study ID Numbers: IND 13724
Study First Received: February 5, 2013
Results First Received: December 20, 2013
Last Updated: March 18, 2014
Health Authority: United States: Food and Drug Administration