Trial Outcomes & Findings for Effect of Rosiglitazone on the Vascular Biology of Human Fat Tissue (NCT NCT01150981)

Results Overview

Adipose tissue collected at 8 weeks was cut into \~1mm pieces which were embedded in individual wells of a 96 well plate containing growth factor depleted Matrigel. Wells were filled with media supplemented with endothelial growth factors, replaced every second day. Values for each patient are expressed as the difference in the average number of capillary branches (sprouts) formed by each of approximately 50 explants between day 14 and day 7. The number of branches forming on the periphery (defined as at least three cells in a branch structure) was counted by two investigators at day 7 and 14.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

35 participants

Primary outcome timeframe

8 weeks

Results posted on

2012-03-26

Participant Flow

dates of recruitment January 2007 to January 2010

Participant milestones

Participant milestones
Measure	Rosiglitazone One 8mg capsule daily for 6 weeks.	Placebo One capsule daily for 6 weeks.
Overall Study STARTED	20	15
Overall Study COMPLETED	16	13
Overall Study NOT COMPLETED	4	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Effect of Rosiglitazone on the Vascular Biology of Human Fat Tissue

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Rosiglitazone n=20 Participants One 8mg capsule daily for 6 weeks.	Placebo n=15 Participants One capsule daily for 6 weeks.	Total n=35 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	20 Participants n=5 Participants	15 Participants n=7 Participants	35 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age Continuous	39.25 years STANDARD_DEVIATION 2.42 • n=5 Participants	40.2 years STANDARD_DEVIATION 10.23 • n=7 Participants	40.09 years STANDARD_DEVIATION 10.43 • n=5 Participants
Sex: Female, Male Female	14 Participants n=5 Participants	11 Participants n=7 Participants	25 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants	4 Participants n=7 Participants	10 Participants n=5 Participants
Region of Enrollment United States	20 participants n=5 Participants	15 participants n=7 Participants	35 participants n=5 Participants

PRIMARY outcome

Timeframe: 8 weeks

Population: The number of subjects was based on the power of calculations in being able to demonstrate a difference from baseline in fat tissue microvasculature, change in HOMA2 and serum adiponectin after 6 weeks of rosiglitazone intake in all groups.

Adipose tissue collected at 8 weeks was cut into \~1mm pieces which were embedded in individual wells of a 96 well plate containing growth factor depleted Matrigel. Wells were filled with media supplemented with endothelial growth factors, replaced every second day. Values for each patient are expressed as the difference in the average number of capillary branches (sprouts) formed by each of approximately 50 explants between day 14 and day 7. The number of branches forming on the periphery (defined as at least three cells in a branch structure) was counted by two investigators at day 7 and 14.

Outcome measures

Outcome measures
Measure	Rosiglitazone n=16 Participants One 8mg capsule daily for 6 weeks.	Placebo n=13 Participants One capsule daily for 6 weeks.
Adipose Tissue Capillary Sprout Formation	143.5 number of capillary sprouts Standard Deviation 41.12	122.1 number of capillary sprouts Standard Deviation 43.88

SECONDARY outcome

Timeframe: 8 weeks

Adiponectin concentrations in serum were measured in ng/ml, in both arms at baseline and at 8 weeks, i.e. 2 weeks after stopping drug or placebo treatment

Outcome measures

Outcome measures
Measure	Rosiglitazone n=16 Participants One 8mg capsule daily for 6 weeks.	Placebo n=13 Participants One capsule daily for 6 weeks.
Serum Adiponectin	28.56 ng/ml Standard Error 2.89	14.64 ng/ml Standard Error 2.86

Adverse Events

Rosiglitazone

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Samir Malkani, MD

University of Massachusetts Medical School

Phone: 5088563800

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place