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Prevention of Metabolic Complications of Glucocorticoid Excess

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ClinicalTrials.gov Identifier: NCT01319994
Recruitment Status : Completed
First Posted : March 22, 2011
Results First Posted : April 12, 2019
Last Update Posted : April 12, 2019
Sponsor:
Collaborator:
Barts and the London School of Medicine and Dentistry
Information provided by (Responsible Party):
Marta Korbonits, Barts & The London NHS Trust

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition Iatrogenic Cushing Disease
Interventions Drug: Metformin
Drug: Placebo
Enrollment 57
Recruitment Details  
Pre-assignment Details Patients were recruited into "Prevention" and "Treatment" algorithms initially. However, only the "Treatment" algorithm proved feasible for logistic reasons. Below are the results relating to patients randomized into the Treatment algorithm.
Arm/Group Title Metformin Placebo
Hide Arm/Group Description Metformin 850mg TDS for 12 weeks Placebo 850mg TDS for 12 weeks
Period Title: Overall Study
Started 26 27
Abto Keep Appoinment Shedule 23 24
Tolerated at Least 1.7g/Day Dose 19 24
Glucocorticoid Dose as Inc Cri 19 22
Did Not Develop Overt Diabetes 19 21
Completed 19 21
Not Completed 7 6
Reason Not Completed
Protocol Violation             7             6
Arm/Group Title Metformin Placebo Total
Hide Arm/Group Description Metformin 850mg TDS Placebo 850mg TDS Total of all reporting groups
Overall Number of Baseline Participants 26 27 53
Hide Baseline Analysis Population Description
Heterogeneous but well matched treatment groups
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 26 participants 27 participants 53 participants
47  (15) 45  (15) 46  (15)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 26 participants 27 participants 53 participants
Female
14
  53.8%
15
  55.6%
29
  54.7%
Male
12
  46.2%
12
  44.4%
24
  45.3%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 26 participants 27 participants 53 participants
Hispanic or Latino
0
   0.0%
0
   0.0%
0
   0.0%
Not Hispanic or Latino
26
 100.0%
27
 100.0%
53
 100.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
visceral to subcutanous fat ratio   [1] 
Median (Inter-Quartile Range)
Unit of measure:  Ratio
Number Analyzed 26 participants 27 participants 53 participants
0.44
(0.33 to 0.67)
0.58
(0.34 to 0.84)
0.50
(0.33 to 0.76)
[1]
Measure Description: Visceral to subcutaneous fat area ratio as assessed by CT at level L4
HOMA2-IR   [1] 
Median (Inter-Quartile Range)
Unit of measure:  HOMA score
Number Analyzed 26 participants 27 participants 53 participants
4.7
(2.2 to 5.5)
4.2
(2.8 to 5.4)
4.4
(2.2 to 5.3)
[1]
Measure Description: The homeostatic model assessment (HOMA) is a method used to quantify insulin resistance using a HOMA model (https://www.dtu.ox.ac.uk/homacalculator/)
1.Primary Outcome
Title CT Abdomen
Hide Description change in visceral/subcutaneous fat
Time Frame 3 months minus baseline
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Metformin Placebo
Hide Arm/Group Description:
Metformin 850mg TDS
Placebo 850mg TDS
Overall Number of Participants Analyzed 19 21
Mean (Standard Deviation)
Unit of Measure: ratio
0.08  (0.19) -0.03  (0.22)
2.Secondary Outcome
Title HOMA2-IR
Hide Description The homeostatic model assessment (HOMA) is a method used to quantify insulin resistance and beta (β)-cell function. HOMA2-IR is a computer model that uses fasting plasma insulin and glucose concentrations to estimate insulin resistance which is the reciprocal of insulin sensitivity (%S)(100/%S) as a percentage of a normal reference population (normal young adults). HOMA2-IR is calculated using the HOMA model: www.dtu.ox.ac.uk/homacalculator/
Time Frame 3 months minus baseline
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Metformin Placebo
Hide Arm/Group Description:
Metformin 850mg TDS
Placebo 850mg TDS
Overall Number of Participants Analyzed 19 21
Mean (Standard Deviation)
Unit of Measure: HOMA score
0.22  (3.26) 2.35  (3.23)
Time Frame 6 months
Adverse Event Reporting Description adverse event definition is matching the definition of clinicaltrials.org
 
Arm/Group Title Metformin Placebo
Hide Arm/Group Description Metformin 850mg TDS for 12 weeks Placebo 850mg TDS for 12 weeks
All-Cause Mortality
Metformin Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Metformin Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   1/26 (3.85%)   9/27 (33.33%) 
Cardiac disorders     
Ischaemic heart disease  1  1/26 (3.85%)  0/27 (0.00%) 
Atypical chest pain  1  0/26 (0.00%)  1/27 (3.70%) 
Endocrine disorders     
Severe osmotic symptoms  1  0/26 (0.00%)  2/27 (7.41%) 
Gastrointestinal disorders     
Diverticulitis  1  0/26 (0.00%)  1/27 (3.70%) 
Respiratory, thoracic and mediastinal disorders     
Pneumonia  1  0/26 (0.00%)  1/27 (3.70%) 
Exacerbation of asthma  1  0/26 (0.00%)  3/27 (11.11%) 
Vascular disorders     
Raynaud's  1  0/26 (0.00%)  1/27 (3.70%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, SNOMED CT
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Metformin Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   26/26 (100.00%)   22/27 (81.48%) 
Gastrointestinal disorders     
Gastrointestinal side-effects  1  16/26 (61.54%)  9/27 (33.33%) 
General disorders     
Other  1  10/26 (38.46%)  18/27 (66.67%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, SNOMED CT
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Prof M Korbonits
Organization: Queen Mary University of London
Phone: +442078826197
EMail: m.korbonits@qmul.ac.uk
Layout table for additonal information
Responsible Party: Marta Korbonits, Barts & The London NHS Trust
ClinicalTrials.gov Identifier: NCT01319994     History of Changes
Other Study ID Numbers: 09/H1102/82
First Submitted: February 21, 2011
First Posted: March 22, 2011
Results First Submitted: July 10, 2015
Results First Posted: April 12, 2019
Last Update Posted: April 12, 2019