ClinicalTrials.gov
ClinicalTrials.gov Menu

Effects of Roflumilast on Insulin and Blood Sugar Levels in Prediabetic Overweight and Obese Individuals

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. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01862029
Recruitment Status : Completed
First Posted : May 24, 2013
Results First Posted : September 3, 2018
Last Update Posted : September 3, 2018
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Heart, Lung, and Blood Institute (NHLBI) )

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Obesity
Intervention: Drug: Roflumilast

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Subjects who passed the telephone screening were invited to undergo further screening in the clinic. A total of 24 subjects were subsequently screened. Among these subjects, 14 subjects met the study's inclusion criteria.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Among the 14 subjects who met the inclusion criteria, 3 subjects withdrew participation prior to starting the study procedures due to expected possibility of noncompliance with the protocol schedule. Two additional subjects were withdrawn for new medical findings prior to their initiation of the study medication.

Reporting Groups
  Description
Subjects Who Took Roflumilast Subjects with overweight/obesity and pre-diabetes were to take Roflumilast, a phosphodiesterase 4 (PDE4) inhibitor, for a total of six weeks. They were to take roflumilast 250mcg daily for the first two weeks and then, 500mcg daily for the remaining four weeks.

Participant Flow:   Overall Study
    Subjects Who Took Roflumilast
STARTED   9 
COMPLETED   8 
NOT COMPLETED   1 
Physician Decision                1 



  Baseline Characteristics

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
Roflumilast Subjects with overweight/obesity and pre-diabetes who started Roflumilast, a phosphodiesterase 4 (PDE4) inhibitor.

Baseline Measures
   Roflumilast 
Overall Participants Analyzed 
[Units: Participants]
 9 
Age 
[Units: Years]
Mean (Standard Deviation)
 49.6  (6.4) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      3  33.3% 
Male      6  66.7% 
Race/Ethnicity, Customized 
[Units: Participants]
Count of Participants
 
Black or African-American   6 
White   2 
Hispanic   1 
Region of Enrollment [1] 
[Units: Participants]
 
United States   9 
[1] Subjects resided either within District of Columbia or within the states of Maryland or Virginia.


  Outcome Measures

1.  Primary:   Change in Insulin Sensitivity- Pre-roflumilast   [ Time Frame: Baseline ]

2.  Primary:   Change in Insulin Sensitivity - Post-roflumilast   [ Time Frame: 6 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

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
The sample size for the assessment of the primary outcome was less than planned.


  More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Jay H. Chung, Ph.D, MD
Organization: National Institute of Health, NHLBI, Laboratory of Obesity and Aging Research
phone: 301-496-3075
e-mail: chungj@nhlbi.nih.gov


Publications:

Responsible Party: National Institutes of Health Clinical Center (CC) ( National Heart, Lung, and Blood Institute (NHLBI) )
ClinicalTrials.gov Identifier: NCT01862029     History of Changes
Other Study ID Numbers: 130123
13-H-0123
First Submitted: May 22, 2013
First Posted: May 24, 2013
Results First Submitted: July 26, 2018
Results First Posted: September 3, 2018
Last Update Posted: September 3, 2018