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

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ClinicalTrials.gov Identifier: NCT01786707
Recruitment Status : Completed
First Posted : February 8, 2013
Results First Posted : April 21, 2014
Last Update Posted : July 2, 2017
Sponsor:
Collaborator:
Diabetes Research Institute Foundation
Information provided by (Responsible Party):
Rodolfo Alejandro, University of Miami

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Condition Type 2 Diabetes Mellitus
Interventions Biological: Autologous stem cells
Other: Hyperbaric oxygen therapy
Drug: Insulin
Drug: Metformin
Enrollment 2
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Autologous Stem Cell and HOT Control Group
Hide Arm/Group Description

Autologous stem cells (SC) 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.

Patients in a control group will continue with standard medical treatment (SMT)
Period Title: Overall Study
Started 1 1
Completed 0 0
Not Completed 1 1
Reason Not Completed
Lost to Follow-up             1             1
Arm/Group Title Autologous SC and HOT Control Group Total
Hide Arm/Group Description

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.

Patients in a control group will continue with standard medical treatment (SMT) Total of all reporting groups
Overall Number of Baseline Participants 1 1 2
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants 1 participants 2 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
1
 100.0%
1
 100.0%
2
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants 1 participants 2 participants
Female
0
   0.0%
1
 100.0%
1
  50.0%
Male
1
 100.0%
0
   0.0%
1
  50.0%
1.Primary Outcome
Title Number of Participants With a Reduction of HbA1c of >0.5%
Hide Description [Not Specified]
Time Frame 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Autologous SC and HOT Control Group
Hide Arm/Group Description:

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.

Patients in a control group will continue with standard medical treatment (SMT)
Overall Number of Participants Analyzed 1 1
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
2.Secondary Outcome
Title The Number of Subjects With a Reduction of >1% in HbA1c
Hide Description [Not Specified]
Time Frame at 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Autologous SC and HOT Control Group
Hide Arm/Group Description:

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.

Patients in a control group will continue with standard medical treatment (SMT)
Overall Number of Participants Analyzed 1 1
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Autologous SC and HOT Control Group
Hide Arm/Group Description

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.

Patients in a control group will continue with standard medical treatment (SMT)
All-Cause Mortality
Autologous SC and HOT Control Group
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Autologous SC and HOT Control Group
Affected / at Risk (%) Affected / at Risk (%)
Total   0/1 (0.00%)   0/1 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Autologous SC and HOT Control Group
Affected / at Risk (%) Affected / at Risk (%)
Total   0/1 (0.00%)   0/1 (0.00%) 
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
Responsible Party: Rodolfo Alejandro, University of Miami
ClinicalTrials.gov Identifier: NCT01786707     History of Changes
Other Study ID Numbers: 20070881
First Submitted: February 5, 2013
First Posted: February 8, 2013
Results First Submitted: December 20, 2013
Results First Posted: April 21, 2014
Last Update Posted: July 2, 2017