Trial Outcomes & Findings for Pioglitazone on Pancreatic Steatosis and Bone Health (NCT NCT00855010)

NCT ID: NCT00855010

Last Updated: 2017-12-13

Results Overview

Pancreatic fat content was determined by proton magnetic resonance spectroscopy (1H-MRS) using a 1.5 Tesla Philips Intera system.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 42 participants
• Primary outcome timeframe: 12 months
• Results posted on: 2017-12-13

Participant Flow

Participant milestones

Measure	Pioglitazone pioglitazone tablet 45 mg once daily pioglitazone: pioglitazone 45 mg daily: 23 subjects	Placebo Pill placebo pill once daily (look-alike pill which contains no active ingredients) placebo: one daily: 19 subjects
Overall Study STARTED	23	19
Overall Study COMPLETED	19	18
Overall Study NOT COMPLETED	4	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Pioglitazone on Pancreatic Steatosis and Bone Health

Baseline characteristics by cohort

Measure	Pioglitazone n=23 Participants pioglitazone tablet 45 mg once daily pioglitazone: pioglitazone 45 mg daily: 23	Placebo Pill n=19 Participants placebo pill once daily (look-alike pill which contains no active ingredients) placebo: one daily: 19	Total n=42 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	22 Participants n=5 Participants	18 Participants n=7 Participants	40 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Age, Continuous	52.6 years STANDARD_DEVIATION 9.9 • n=5 Participants	52.2 years STANDARD_DEVIATION 10.6 • n=7 Participants	52.4 years STANDARD_DEVIATION 10.3 • n=5 Participants
Sex: Female, Male Female	11 Participants n=5 Participants	16 Participants n=7 Participants	27 Participants n=5 Participants
Sex: Female, Male Male	12 Participants n=5 Participants	3 Participants n=7 Participants	15 Participants n=5 Participants
Region of Enrollment United States	23 Participants n=5 Participants	19 Participants n=7 Participants	42 Participants n=5 Participants

PRIMARY outcome

Timeframe: 12 months

Pancreatic fat content was determined by proton magnetic resonance spectroscopy (1H-MRS) using a 1.5 Tesla Philips Intera system.

Outcome measures

Measure	Pioglitazone n=23 Participants pioglitazone tablet 45 mg once daily pioglitazone: pioglitazone 45 mg daily: 23 subjects	Placebo Pill n=19 Participants placebo pill once daily (look-alike pill which contains no active ingredients) placebo: one daily: 19 subjects
Pancreatic Fat Content	9.6 Percentage of fat Interval 5.1 to 16.6	13.0 Percentage of fat Interval 6.1 to 20.2

PRIMARY outcome

Timeframe: 12 months

Intact parathyroid hormone (PTH) were measured using enzyme-linked immunosorbent assay. .

Outcome measures

Measure	Pioglitazone n=23 Participants pioglitazone tablet 45 mg once daily pioglitazone: pioglitazone 45 mg daily: 23 subjects	Placebo Pill n=19 Participants placebo pill once daily (look-alike pill which contains no active ingredients) placebo: one daily: 19 subjects
Bone Turnover Marker - Intact Parathyroid Hormone (PTH)	41 pg/mL Interval 38.0 to 57.0	56 pg/mL Interval 51.0 to 74.0

PRIMARY outcome

Timeframe: 12 months

Plasma 25-hydroxyvitamin D was determined by radioimmunoassay

Outcome measures

Measure	Pioglitazone n=23 Participants pioglitazone tablet 45 mg once daily pioglitazone: pioglitazone 45 mg daily: 23 subjects	Placebo Pill n=19 Participants placebo pill once daily (look-alike pill which contains no active ingredients) placebo: one daily: 19 subjects
Bone Turnover Marker - Plasma 25-hydroxyvitamin D	25 ng/mL Interval 15.0 to 30.0	19 ng/mL Interval 14.0 to 25.0

SECONDARY outcome

Timeframe: 12 months

Changes in B-cell function as measured by acute insulin release to glucose (AIRg)

Outcome measures

Measure	Pioglitazone n=23 Participants pioglitazone tablet 45 mg once daily pioglitazone: pioglitazone 45 mg daily: 23 subjects	Placebo Pill n=19 Participants placebo pill once daily (look-alike pill which contains no active ingredients) placebo: one daily: 19 subjects
Beta-cell Function	101 microUnits/mL x min Interval 40.0 to 352.0	494 microUnits/mL x min Interval 264.0 to 748.0

SECONDARY outcome

Timeframe: 12 months

Hepatic fat content was determined by proton magnetic resonance spectroscopy (1H-MRS) using a 1.5 Tesla Philips Intera system.

Outcome measures

Measure	Pioglitazone n=23 Participants pioglitazone tablet 45 mg once daily pioglitazone: pioglitazone 45 mg daily: 23 subjects	Placebo Pill n=19 Participants placebo pill once daily (look-alike pill which contains no active ingredients) placebo: one daily: 19 subjects
Hepatic Fat Content	4.0 percentage Interval 1.7 to 10.9	5.8 percentage Interval 3.6 to 16.0

SECONDARY outcome

Timeframe: 12 months

Abdominal MRI was performed to quantify subcutaneous fat area at the L2-L3 level.

Outcome measures

Measure	Pioglitazone n=23 Participants pioglitazone tablet 45 mg once daily pioglitazone: pioglitazone 45 mg daily: 23 subjects	Placebo Pill n=19 Participants placebo pill once daily (look-alike pill which contains no active ingredients) placebo: one daily: 19 subjects
Subcutaneous Fat Area	243 cm^2 Standard Deviation 133	378 cm^2 Standard Deviation 179

SECONDARY outcome

Timeframe: 12 months

Abdominal MRI was performed to quantify visceral fat area at the L2-L3 level.

Outcome measures

Measure	Pioglitazone n=23 Participants pioglitazone tablet 45 mg once daily pioglitazone: pioglitazone 45 mg daily: 23 subjects	Placebo Pill n=19 Participants placebo pill once daily (look-alike pill which contains no active ingredients) placebo: one daily: 19 subjects
Visceral Fat Area	302 cm^2 Standard Deviation 88	273 cm^2 Standard Deviation 89

SECONDARY outcome

Timeframe: 12 months

Areal Bone Mineral Density at the L2-L4 antero-posterior lumbar spine, left femoral neck and total hip were measured by DXA scan using a Hologic Discovery Instrument scanner.

Outcome measures

Measure	Pioglitazone n=23 Participants pioglitazone tablet 45 mg once daily pioglitazone: pioglitazone 45 mg daily: 23 subjects	Placebo Pill n=19 Participants placebo pill once daily (look-alike pill which contains no active ingredients) placebo: one daily: 19 subjects
Bone Mineral Density L2-L4 Lumbar spine BMD	1.03 g/cm^2 Standard Deviation 0.14	1.03 g/cm^2 Standard Deviation 0.14
Bone Mineral Density Left femoral neck	0.83 g/cm^2 Standard Deviation 0.09	0.85 g/cm^2 Standard Deviation 0.13
Bone Mineral Density Left total hip	0.96 g/cm^2 Standard Deviation 0.12	1.02 g/cm^2 Standard Deviation 0.12

SECONDARY outcome

Timeframe: 12 months

Disposition index is a measure of insulin secretion multiplied by insulin sensitivity, both derived from intravenous glucose tolerance test. A higher number means the pancreas is better able to lower blood glucose and a lower number means the pancreas is less able to lower blood glucose

Outcome measures

Measure	Pioglitazone n=23 Participants pioglitazone tablet 45 mg once daily pioglitazone: pioglitazone 45 mg daily: 23 subjects	Placebo Pill n=19 Participants placebo pill once daily (look-alike pill which contains no active ingredients) placebo: one daily: 19 subjects
Disposition Index	410 Unitless Interval 118.0 to 1458.0	841 Unitless Interval 487.0 to 1491.0

Adverse Events

Pioglitazone

Serious events: 2 serious events

Other events: 7 other events

Deaths: 0 deaths

Placebo Pill

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Measure	Pioglitazone n=23 participants at risk pioglitazone tablet 45 mg once daily pioglitazone: pioglitazone 45 mg daily: 23 subjects	Placebo Pill n=19 participants at risk placebo pill once daily (look-alike pill which contains no active ingredients) placebo: one daily: 19 subjects
Infections and infestations Bacteremia with Streptococcus pneumoniae	4.3% 1/23 • Number of events 1	0.00% 0/19
Surgical and medical procedures Motor vehicle trauma	4.3% 1/23 • Number of events 1	0.00% 0/19
Surgical and medical procedures Right ankle trauma	4.3% 1/23 • Number of events 1	0.00% 0/19

Other adverse events

Measure	Pioglitazone n=23 participants at risk pioglitazone tablet 45 mg once daily pioglitazone: pioglitazone 45 mg daily: 23 subjects	Placebo Pill n=19 participants at risk placebo pill once daily (look-alike pill which contains no active ingredients) placebo: one daily: 19 subjects
General disorders Lose consciousness	0.00% 0/23	5.3% 1/19 • Number of events 1
Reproductive system and breast disorders Menorrhagia	0.00% 0/23	5.3% 1/19 • Number of events 1
General disorders Fingers edema	8.7% 2/23 • Number of events 2	5.3% 1/19 • Number of events 1
General disorders Trauma	8.7% 2/23 • Number of events 2	15.8% 3/19 • Number of events 3
Renal and urinary disorders Urinary tract infection	0.00% 0/23	5.3% 1/19 • Number of events 1
Hepatobiliary disorders Fatigue	4.3% 1/23 • Number of events 1	0.00% 0/19
General disorders Headache	4.3% 1/23 • Number of events 1	0.00% 0/19
Musculoskeletal and connective tissue disorders Muscle cramps	4.3% 1/23 • Number of events 1	0.00% 0/19
Musculoskeletal and connective tissue disorders Lipoma	4.3% 1/23 • Number of events 1	0.00% 0/19
Musculoskeletal and connective tissue disorders Shoulder arthroplasty	4.3% 1/23 • Number of events 1	0.00% 0/19

Additional Information

Ildiko Lingvay

UT Southwestern Medical Center

Phone: 214-648-2779

Email: ildiko.lingvay@utsouthwestern.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place