Trial Outcomes & Findings for The Effects of Anti-Inflammatory Treatment on Insulin Resistance in Healthy Volunteers (NCT NCT00339833)

NCT ID: NCT00339833

Last Updated: 2013-03-06

Results Overview

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

54 participants

Primary outcome timeframe

7 days

Results posted on

2013-03-06

Participant Flow

Recruitment location: clinical research unit at the NIDKK (Phoenix, AZ, USA)

Upon admission, all participants were placed on a weight maintaining diet (containing 50% of energy as carbohydrate, 30% as fat and 20% as protein). Body composition was measured by dual-energy x-ray absorptiometry. At least 3 days after admission and after a 12 h overnight fast a 2-h 75 g OGTT was performed to exclude diabetes.

Participant milestones

Participant milestones
Measure	Salsalate The intervention was salsalate (3g/day) for 7 days	Placebo Placebo for 7 days.
Overall Study STARTED	28	26
Overall Study COMPLETED	22	18
Overall Study NOT COMPLETED	6	8

Reasons for withdrawal

Reasons for withdrawal
Measure	Salsalate The intervention was salsalate (3g/day) for 7 days	Placebo Placebo for 7 days.
Overall Study Withdrawal by Subject	1	2
Overall Study toothache	0	1
Overall Study indigestion	0	1
Overall Study Chest pain	0	1
Overall Study minor infection	0	1
Overall Study Poor venous access	2	2
Overall Study anaemia or excess drop in glycaemia	2	0
Overall Study Error in data records	1	0

Baseline Characteristics

The Effects of Anti-Inflammatory Treatment on Insulin Resistance in Healthy Volunteers

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Salsalate n=22 Participants Salsalate (3g/day) for 7 days	Placebo n=18 Participants Identical placebo for 7 days	Total n=40 Participants Total of all reporting groups
Age Continuous	29 years STANDARD_DEVIATION 7 • n=99 Participants	33 years STANDARD_DEVIATION 8 • n=107 Participants	31 years STANDARD_DEVIATION 7.5 • n=206 Participants
Sex: Female, Male Female	12 Participants n=99 Participants	9 Participants n=107 Participants	21 Participants n=206 Participants
Sex: Female, Male Male	10 Participants n=99 Participants	9 Participants n=107 Participants	19 Participants n=206 Participants
Race/Ethnicity, Customized Hispanic	0 participants n=99 Participants	1 participants n=107 Participants	1 participants n=206 Participants
Race/Ethnicity, Customized White	3 participants n=99 Participants	3 participants n=107 Participants	6 participants n=206 Participants
Race/Ethnicity, Customized Native American	19 participants n=99 Participants	14 participants n=107 Participants	33 participants n=206 Participants
Region of Enrollment United States	22 participants n=99 Participants	18 participants n=107 Participants	40 participants n=206 Participants
BMI	37 kg/m2 STANDARD_DEVIATION 5 • n=99 Participants	38 kg/m2 STANDARD_DEVIATION 6 • n=107 Participants	37.5 kg/m2 STANDARD_DEVIATION 5.5 • n=206 Participants
Body Fat	38 % body fat STANDARD_DEVIATION 6 • n=99 Participants	38 % body fat STANDARD_DEVIATION 7 • n=107 Participants	38 % body fat STANDARD_DEVIATION 6.5 • n=206 Participants
Fasting plasma glucose	5.11 mmol/l STANDARD_DEVIATION 0.33 • n=99 Participants	5.06 mmol/l STANDARD_DEVIATION 0.33 • n=107 Participants	5.09 mmol/l STANDARD_DEVIATION 0.33 • n=206 Participants
2 hour plasma glucose	6.67 mmol/l STANDARD_DEVIATION 1.17 • n=99 Participants	6.61 mmol/l STANDARD_DEVIATION 1.83 • n=107 Participants	6.64 mmol/l STANDARD_DEVIATION 1.50 • n=206 Participants
Fasting plasma insulin	80 pmol/l n=99 Participants	63 pmol/l n=107 Participants	76 pmol/l n=206 Participants
Basal EGP	10 micro-mol/(kg*min) STANDARD_DEVIATION 2 • n=99 Participants	11 micro-mol/(kg*min) STANDARD_DEVIATION 2 • n=107 Participants	10.5 micro-mol/(kg*min) STANDARD_DEVIATION 2 • n=206 Participants
Clamp R_d	13 micro-mol/(kg*min) n=99 Participants	16 micro-mol/(kg*min) n=107 Participants	14 micro-mol/(kg*min) n=206 Participants

PRIMARY outcome

Timeframe: 7 days

Outcome measures

Outcome measures
Measure	Salsalate n=22 Participants Salsalate (3g/day) for 7 days	Placebo n=18 Participants Identical placebo for 7 days
Change in Fasting Plasma Glucose Concentration	4.7 mmol/l Standard Deviation 6.5	0.0 mmol/l Standard Deviation 3.7

PRIMARY outcome

Timeframe: last 40 min of clamp

Outcome measures

Outcome measures
Measure	Salsalate n=22 Participants Salsalate (3g/day) for 7 days	Placebo n=18 Participants Identical placebo for 7 days
Change in the Average Serum Insulin Concentration During the Last 40 Min of Clamp	0.15 l/min Standard Deviation 0.21	-0.06 l/min Standard Deviation 0.23

Adverse Events

Salsalate

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

Jonathan Krakoff, M.D./National Institute of Diabetes and Digestive and Kidney Diseases

National Institutes of Health

Phone: 6022005217

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place