Trial Outcomes & Findings for Adipokines in Obese Adolescents With Insulin Resistance (NCT NCT01410604)

NCT ID: NCT01410604

Last Updated: 2012-04-27

Results Overview

Change from baseline in Adiponectin after 3 months of treatment.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 31 participants
• Primary outcome timeframe: baseline and 3 months
• Results posted on: 2012-04-27

Participant Flow

Subjects were enrolled between January 2007 and December 2009 in the Pediatric Obesity Clinics (POC) from third level Mexican Hospitals: the HMFG, located in the Federal District (country's capital), and the HRAEB, located in the city of Leon in the state of Guanajauto.

Participant milestones

Measure	Metformin	Placebo
Overall Study STARTED	15	16
Overall Study COMPLETED	12	14
Overall Study NOT COMPLETED	3	2

Reasons for withdrawal

Measure	Metformin	Placebo
Overall Study Adverse Event	2	1
Overall Study Lost to Follow-up	1	0
Overall Study Physician Decision	0	1

Baseline Characteristics

Adipokines in Obese Adolescents With Insulin Resistance

Baseline characteristics by cohort

Measure	Metformin n=15 Participants	Placebo n=16 Participants	Total n=31 Participants Total of all reporting groups
Age, Categorical <=18 years	15 Participants n=5 Participants	16 Participants n=7 Participants	31 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 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	12.56 years STANDARD_DEVIATION 2.25 • n=5 Participants	14.12 years STANDARD_DEVIATION 1.20 • n=7 Participants	13.37 years STANDARD_DEVIATION 1.92 • n=5 Participants
Sex: Female, Male Female	12 Participants n=5 Participants	10 Participants n=7 Participants	22 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	6 Participants n=7 Participants	9 Participants n=5 Participants
Region of Enrollment Mexico	15 participants n=5 Participants	16 participants n=7 Participants	31 participants n=5 Participants

PRIMARY outcome

Timeframe: baseline and 3 months

Change from baseline in Adiponectin after 3 months of treatment.

Outcome measures

Measure	Metformin n=12 Participants	Placebo n=14 Participants
Adiponectin	-0.71 µg/mL Standard Deviation 4.29	-7.52 µg/mL Standard Deviation 6.28

PRIMARY outcome

Timeframe: baseline and 3 months

Change from baseline in High-sensitivity C-reactive protein after 3 months of treatment.

Outcome measures

Measure	Metformin n=12 Participants	Placebo n=14 Participants
High-sensitivity C-reactive Protein	-1.26 mg/dL Standard Deviation 4.40	-1.35 mg/dL Standard Deviation 13.60

PRIMARY outcome

Timeframe: baseline and 3 months

Change from baseline in Interleukin 6 after 3 months of treatment.

Outcome measures

Measure	Metformin n=12 Participants	Placebo n=14 Participants
Interleukin 6	-34.09 pg/mL Standard Deviation 145.72	16.42 pg/mL Standard Deviation 60.50

PRIMARY outcome

Timeframe: baseline and 3 months

Change from baseline in Tumour necrosis factor alpha after 3 months of treatment.

Outcome measures

Measure	Metformin n=12 Participants	Placebo n=14 Participants
Tumour Necrosis Factor Alpha	-34.08 pg/mL Standard Deviation 77.58	-4.01 pg/mL Standard Deviation 31.82

SECONDARY outcome

Timeframe: baseline and 3 months

Change from baseline in Fasting plasma glucose after 3 months of treatment.

Outcome measures

Measure	Metformin n=12 Participants	Placebo n=14 Participants
Fasting Plasma Glucose	-1.08 mg/dL Standard Deviation 11.39	1.71 mg/dL Standard Deviation 15.61

SECONDARY outcome

Timeframe: baseline and 3 months

Change from baseline in Fasting insulin after 3 months of treatment.

Outcome measures

Measure	Metformin n=12 Participants	Placebo n=14 Participants
Fasting Insulin	-3.97 µU/mL Standard Deviation 23.28	11.03 µU/mL Standard Deviation 14.37

SECONDARY outcome

Timeframe: baseline and 3 months

Change from baseline in Body Mass Index after 3 months of treatment.

Outcome measures

Measure	Metformin n=12 Participants	Placebo n=14 Participants
Body Mass Index	-0.74 kg/m^2 Standard Deviation 0.83	-0.71 kg/m^2 Standard Deviation 0.85

SECONDARY outcome

Timeframe: baseline and 3 months

Change from baseline in Waist circumference after 3 months of treatment.

Outcome measures

Measure	Metformin n=12 Participants	Placebo n=14 Participants
Waist Circumference	-0.57 cm Standard Deviation 4.28	-3.29 cm Standard Deviation 5.24

Adverse Events

Metformin

Serious events: 2 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Metformin n=15 participants at risk	Placebo n=16 participants at risk
Gastrointestinal disorders Epigastric pain	13.3% 2/15 • Number of events 2 • 3 months	6.2% 1/16 • Number of events 1 • 3 months

Other adverse events

Adverse event data not reported

Additional Information

M.D. Maria L. Evia-Viscarra

Hospital Regional de Alta Especialidad del Bajio

Phone: +52 (477) 267-2000

Email: evialola@hotmail.com

Results disclosure agreements

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