ObesityPhase 4NCT01410604

Adipokines in Obese Adolescents With Insulin Resistance

A Phase 4 study testing Metformin in people with Obesity, run by Hospital Regional de Alta Especialidad del Bajio at 2 sites in Mexico.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

The purpose of this study is to compare serum concentrations of inflammatory cytokines, interleukin 6 (IL-6), High-sensitivity C-reactive protein (hs-CRP), adiponectin, and tumour necrosis factor alpha (TNFα), before and after three months treatment with metformin in obese adolescents with insulin resistance (IR). Read more about this study

Who is it for?: Ages 9 to 18 years
Conditions the study is for: Obesity
What is being tested?: Metformin
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 31 participants
Where: 2 sitesMexico
Study dates: Jan 2007to Mar 2010
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 9 to 18 years
All sexes
No healthy volunteers
Child, Adult

Who may be able to join

Obesity defined as Body Mass Index (BMI) ≥ percentile 95
Tanner stage ≥ 2
Insulin resistance defined as Basal insulin > 15 µU/mL or Homeostasis Model Assessment index (HOMA) > 4.5
Patients' parents signed written consents when they and their adolescent children agreed to enroll

Who cannot join

Glucose intolerance
Diabetes mellitus (type 1 or 2)
Anemia (Hb < 10 g/dL)
Plasma creatinine > 1.4 mg/dL
Abnormal hepatic function
Any associated Disease (Pulmonary, Infection, Autoimmune Disease)
History of lactic acidosis

Trial locations and contacts

2 sites in 1 country.

Mexico2 sites

Hospital Regional de Alta Especialidad del Bajío
León, Guanajuato, 37670
Hospital Infantil de México Federico Gómez
Mexico City, Mexico City, 06720

Other trials in Mexico

About this study

Official title: Inflammatory Mediators in Obese Adolescents With Insulin Resistance Following Metformin Treatment: Controlled Randomized Clinical Trial

Read the detailed description

The increased prevalence of obesity in pediatric patients is a public health problem particularly because of the difficulties involved with changing lifestyles. Current studies of obese children and adolescents show increased insulin resistance (IR) and chronic inflammatory states. These conditions increase the risk of disability and/or premature death.

The current treatment schemes for obese children are conservative and are focused on changing their lifestyles (exercise and dietary plans). However, metabolic conditions, such as IR, dyslipidemia, and inflammatory processes, are perpetuated.

Metformin is a biguanide that is used for adolescents with diabetes mellitus and polycystic ovarian syndrome. Several clinical trials with metformin for obese pediatric patients have observed decreases in IR, decreases in weight, and improvements in lipid metabolism.

Adipose tissue is not only an energy repository, but also plays an immunological role by the secretion of cytokines. Both overweight adults and adolescents show decreases in adiponectin levels and increases in tumor necrosis factor alpha (TNFα) and interleukin 6 (IL-6). IL-6 can stimulate the production of high-sensitivity C-reactive protein (hs-CRP), which is considered to be a risk marker for the development of cardiovascular disease.

Conditions: Obesity
Being tested: Metformin, Placebo
Keywords: Metformin, Obesity, Insulin resistance, Interleukin six, Adiponectin, High sensitivity C reactive protein., Tumour Necrosis Factor alpha
Medical subject headings: Obesity, Insulin Resistance

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

MetforminDrug
Also called Dabex
Tablet of 500 mg metformin, oral every 12 hours (total metformin dose of 1 g/day) for 3 months.
PlaceboDrug
Tablet of 500 mg oral placebo every 12 hours for 3 months.

Study groups in NCT01410604
Study group	Role	What they receive
Metformin	Experimental	Tablet of 500 mg metformin, oral every 12 hours (total metformin dose of 1 g/day) for 3 months. Receives: Drug: Metformin
Placebo	Placebo comparator	Tablet of 500 mg oral placebo every 12 hours for 3 months. Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Adiponectin
Change from baseline in Adiponectin after 3 months of treatment.
Measured: baseline and 3 months
High-sensitivity C-reactive Protein
Change from baseline in High-sensitivity C-reactive protein after 3 months of treatment.
Measured: baseline and 3 months
Interleukin 6
Change from baseline in Interleukin 6 after 3 months of treatment.
Measured: baseline and 3 months
Tumour Necrosis Factor Alpha
Change from baseline in Tumour necrosis factor alpha after 3 months of treatment.
Measured: baseline and 3 months

Secondary outcomes (4)

Fasting Plasma Glucose
Change from baseline in Fasting plasma glucose after 3 months of treatment.
Measured: baseline and 3 months
Fasting Insulin
Change from baseline in Fasting insulin after 3 months of treatment.
Measured: baseline and 3 months
Body Mass Index
Change from baseline in Body Mass Index after 3 months of treatment.
Measured: baseline and 3 months
Waist Circumference
Change from baseline in Waist circumference after 3 months of treatment.
Measured: baseline and 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2007Mar 2010

First posted5 Aug 2011 (estimated)
Study startJan 2007
Primary completionDec 2009
Study completionMar 2010

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (38)Papers the sponsor has linked to this study.
Other trials for ObesityStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 31 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01410604
Sponsor's protocol ID: 010-08
Status last verified: Apr 2012
First submitted: 4 Aug 2011
Last updated: 27 Apr 2012
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Centers for Disease Control and Prevention (CDC). CDC grand rounds: childhood obesity in the United States. MMWR Morb Mortal Wkly Rep. 2011 Jan 21;60(2):42-6.
PubMed 21248681
Wilfley DE, Tibbs TL, Van Buren DJ, Reach KP, Walker MS, Epstein LH. Lifestyle interventions in the treatment of childhood overweight: a meta-analytic review of randomized controlled trials. Health Psychol. 2007 Sep;26(5):521-32. doi: 10.1037/0278-6133.26.5.521.
PubMed 17845100
Zeller M, Kirk S, Claytor R, Khoury P, Grieme J, Santangelo M, Daniels S. Predictors of attrition from a pediatric weight management program. J Pediatr. 2004 Apr;144(4):466-70. doi: 10.1016/j.jpeds.2003.12.031.
PubMed 15069394
Ten S, Maclaren N. Insulin resistance syndrome in children. J Clin Endocrinol Metab. 2004 Jun;89(6):2526-39. doi: 10.1210/jc.2004-0276.
PubMed 15181020
Chiarelli F, Marcovecchio ML. Insulin resistance and obesity in childhood. Eur J Endocrinol. 2008 Dec;159 Suppl 1:S67-74. doi: 10.1530/EJE-08-0245. Epub 2008 Sep 19.
PubMed 18805916
Cruz ML, Weigensberg MJ, Huang TT, Ball G, Shaibi GQ, Goran MI. The metabolic syndrome in overweight Hispanic youth and the role of insulin sensitivity. J Clin Endocrinol Metab. 2004 Jan;89(1):108-13. doi: 10.1210/jc.2003-031188.
PubMed 14715836
Visser M, Bouter LM, McQuillan GM, Wener MH, Harris TB. Low-grade systemic inflammation in overweight children. Pediatrics. 2001 Jan;107(1):E13. doi: 10.1542/peds.107.1.e13.
PubMed 11134477
Freedman DS, Mei Z, Srinivasan SR, Berenson GS, Dietz WH. Cardiovascular risk factors and excess adiposity among overweight children and adolescents: the Bogalusa Heart Study. J Pediatr. 2007 Jan;150(1):12-17.e2. doi: 10.1016/j.jpeds.2006.08.042.
PubMed 17188605
Beauloye V, Zech F, Tran HT, Clapuyt P, Maes M, Brichard SM. Determinants of early atherosclerosis in obese children and adolescents. J Clin Endocrinol Metab. 2007 Aug;92(8):3025-32. doi: 10.1210/jc.2007-0619. Epub 2007 May 22.
PubMed 17519311
Berenson GS, Srinivasan SR, Bao W, Newman WP 3rd, Tracy RE, Wattigney WA. Association between multiple cardiovascular risk factors and atherosclerosis in children and young adults. The Bogalusa Heart Study. N Engl J Med. 1998 Jun 4;338(23):1650-6. doi: 10.1056/NEJM199806043382302.
PubMed 9614255
Type 2 diabetes in children and adolescents. American Diabetes Association. Pediatrics. 2000 Mar;105(3 Pt 1):671-80. doi: 10.1542/peds.105.3.671. No abstract available.
PubMed 10699131
SEARCH for Diabetes in Youth Study Group; Liese AD, D'Agostino RB Jr, Hamman RF, Kilgo PD, Lawrence JM, Liu LL, Loots B, Linder B, Marcovina S, Rodriguez B, Standiford D, Williams DE. The burden of diabetes mellitus among US youth: prevalence estimates from the SEARCH for Diabetes in Youth Study. Pediatrics. 2006 Oct;118(4):1510-8. doi: 10.1542/peds.2006-0690.
PubMed 17015542
Kay JP, Alemzadeh R, Langley G, D'Angelo L, Smith P, Holshouser S. Beneficial effects of metformin in normoglycemic morbidly obese adolescents. Metabolism. 2001 Dec;50(12):1457-61. doi: 10.1053/meta.2001.28078.
PubMed 11735093
Love-Osborne K, Sheeder J, Zeitler P. Addition of metformin to a lifestyle modification program in adolescents with insulin resistance. J Pediatr. 2008 Jun;152(6):817-22. doi: 10.1016/j.jpeds.2008.01.018. Epub 2008 Mar 19.
PubMed 18492523
Srinivasan S, Ambler GR, Baur LA, Garnett SP, Tepsa M, Yap F, Ward GM, Cowell CT. Randomized, controlled trial of metformin for obesity and insulin resistance in children and adolescents: improvement in body composition and fasting insulin. J Clin Endocrinol Metab. 2006 Jun;91(6):2074-80. doi: 10.1210/jc.2006-0241. Epub 2006 Apr 4.
PubMed 16595599

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingObservational study
Endoscopic Sleeve Gastroplasty (ESG) Prospective Trial for Obesity (EGO-Trial)
Obesity
Active, not recruitingPhase 4
Effects of Sequential Therapy With Mexidol® (Intravenous) and Mexidol® FORTE 250 (Oral) on Functional Brain Activity Assessed by Functional Magnetic Resonance Imaging and Biochemical Parameters in Patients With Chronic Cerebral Ischemia: A Comparison of Patients With and Without Metabolic Disorders
Metabolic Abnormalities, Obesity & Overweight
Recruiting
Exercise Training and Vitamin D Metabolism
Obesity & Overweight, Vitamin D
Recruiting
Metabolic Health, Bones and Nuts During Weight Loss in Adults
Weight Loss, Bone Density
Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)

All Obesity trials

Study at a glance

From the registry record, last updated by the sponsor on 27 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Inflammatory Mediators in Obese Adolescents With Insulin Resistance Following Metformin Treatment: Controlled Randomized Clinical Trial
ClinicalTrials.gov ID: NCT01410604
Acronym / sponsor ID: 010-08
Conditions: Obesity
Keywords: Metformin, Obesity, Insulin resistance, Interleukin six, Adiponectin, High sensitivity C reactive protein., Tumour Necrosis Factor alpha
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 31 participants (actual)
Lead sponsor: Hospital Regional de Alta Especialidad del BajioUniversity, hospital or other
Collaborators: Hospital Infantil de Mexico Federico Gomez
Study start: Jan 2007
Primary completion: Dec 2009 (actual)
Study completion: Mar 2010 (actual)
First posted: 5 Aug 2011 (estimated)
Results: Posted 23 Apr 2012

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Metformin	Experimental	Drug: MetforminTablet of 500 mg metformin, oral every 12 hours (total metformin dose of 1 g/day) for 3 months.
Placebo	Placebo comparator	Drug: PlaceboTablet of 500 mg oral placebo every 12 hours for 3 months.

Who may qualify

Ages: 9 to 18 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult

Key inclusion criteria (4 listed)

Obesity defined as Body Mass Index (BMI) ≥ percentile 95
Tanner stage ≥ 2
Insulin resistance defined as Basal insulin > 15 µU/mL or Homeostasis Model Assessment index (HOMA) > 4.5
Patients' parents signed written consents when they and their adolescent children agreed to enroll

Key exclusion criteria (7 listed)

Glucose intolerance
Diabetes mellitus (type 1 or 2)
Anemia (Hb < 10 g/dL)
Plasma creatinine > 1.4 mg/dL
Abnormal hepatic function

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
MetforminAlso: DabexTablet of 500 mg metformin, oral every 12 hours (total metformin dose of 1 g/day) for 3 months.	Drug	Metformin
PlaceboTablet of 500 mg oral placebo every 12 hours for 3 months.	Drug	Placebo

Primary outcome

Adiponectin
Time frame: baseline and 3 months
Change from baseline in Adiponectin after 3 months of treatment.
High-sensitivity C-reactive Protein
Time frame: baseline and 3 months
Change from baseline in High-sensitivity C-reactive protein after 3 months of treatment.
Interleukin 6
Time frame: baseline and 3 months
Change from baseline in Interleukin 6 after 3 months of treatment.
Tumour Necrosis Factor Alpha
Time frame: baseline and 3 months
Change from baseline in Tumour necrosis factor alpha after 3 months of treatment.

4 secondary outcomes

Fasting Plasma Glucose
Time frame: baseline and 3 months
Fasting Insulin
Time frame: baseline and 3 months
Body Mass Index
Time frame: baseline and 3 months
Waist Circumference
Time frame: baseline and 3 months

Results and safety

Results posted to the registry on 23 Apr 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Metformin	15	12
Placebo	16	14

Primary outcome: Adiponectin

Time frame: baseline and 3 months. Mean (Standard Deviation). Unit: µg/mL

Measure	Metformin n = 12	Placebo n = 14
Value	-0.71 (4.29)	-7.52 (6.28)

Primary outcome: High-sensitivity C-reactive Protein

Time frame: baseline and 3 months. Mean (Standard Deviation). Unit: mg/dL

Measure	Metformin n = 12	Placebo n = 14
Value	-1.26 (4.40)	-1.35 (13.60)

Primary outcome: Interleukin 6

Time frame: baseline and 3 months. Mean (Standard Deviation). Unit: pg/mL

Measure	Metformin n = 12	Placebo n = 14
Value	-34.09 (145.72)	16.42 (60.50)

Primary outcome: Tumour Necrosis Factor Alpha

Time frame: baseline and 3 months. Mean (Standard Deviation). Unit: pg/mL

Measure	Metformin n = 12	Placebo n = 14
Value	-34.08 (77.58)	-4.01 (31.82)

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: 3 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Metformin	2 of 15 (13.3%)	0 of 15 (0%)	Not reported
Placebo	1 of 16 (6.3%)	0 of 16 (0%)	Not reported

Limitations and caveats (from the sponsor): During the recruitment phase, 83 children who were diagnosed with obesity and acanthosis nigricans were evaluated. Of these, 45 did not have the insulin concentration values (\>15 µU/mL) required to biochemically define Insulin Resistance.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2012.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 21248681Centers for Disease Control and Prevention (CDC). CDC grand rounds: childhood obesity in the United States. MMWR Morb Mortal Wkly Rep. 2011 Jan 21;60(2):42-6.
Background: PubMed 17845100Wilfley DE, Tibbs TL, Van Buren DJ, Reach KP, Walker MS, Epstein LH. Lifestyle interventions in the treatment of childhood overweight: a meta-analytic review of randomized controlled trials. Health Psychol. 2007 Sep;26(5):521-32. doi: 10.1037/0278-6133.26.5.521.
Background: PubMed 15069394Zeller M, Kirk S, Claytor R, Khoury P, Grieme J, Santangelo M, Daniels S. Predictors of attrition from a pediatric weight management program. J Pediatr. 2004 Apr;144(4):466-70. doi: 10.1016/j.jpeds.2003.12.031.
Background: PubMed 15181020Ten S, Maclaren N. Insulin resistance syndrome in children. J Clin Endocrinol Metab. 2004 Jun;89(6):2526-39. doi: 10.1210/jc.2004-0276.
Background: PubMed 18805916Chiarelli F, Marcovecchio ML. Insulin resistance and obesity in childhood. Eur J Endocrinol. 2008 Dec;159 Suppl 1:S67-74. doi: 10.1530/EJE-08-0245. Epub 2008 Sep 19.
Background: PubMed 14715836Cruz ML, Weigensberg MJ, Huang TT, Ball G, Shaibi GQ, Goran MI. The metabolic syndrome in overweight Hispanic youth and the role of insulin sensitivity. J Clin Endocrinol Metab. 2004 Jan;89(1):108-13. doi: 10.1210/jc.2003-031188.
Background: PubMed 11134477Visser M, Bouter LM, McQuillan GM, Wener MH, Harris TB. Low-grade systemic inflammation in overweight children. Pediatrics. 2001 Jan;107(1):E13. doi: 10.1542/peds.107.1.e13.
Background: PubMed 17188605Freedman DS, Mei Z, Srinivasan SR, Berenson GS, Dietz WH. Cardiovascular risk factors and excess adiposity among overweight children and adolescents: the Bogalusa Heart Study. J Pediatr. 2007 Jan;150(1):12-17.e2. doi: 10.1016/j.jpeds.2006.08.042.
Background: PubMed 17519311Beauloye V, Zech F, Tran HT, Clapuyt P, Maes M, Brichard SM. Determinants of early atherosclerosis in obese children and adolescents. J Clin Endocrinol Metab. 2007 Aug;92(8):3025-32. doi: 10.1210/jc.2007-0619. Epub 2007 May 22.
Background: PubMed 9614255Berenson GS, Srinivasan SR, Bao W, Newman WP 3rd, Tracy RE, Wattigney WA. Association between multiple cardiovascular risk factors and atherosclerosis in children and young adults. The Bogalusa Heart Study. N Engl J Med. 1998 Jun 4;338(23):1650-6. doi: 10.1056/NEJM199806043382302.
Background: PubMed 10699131Type 2 diabetes in children and adolescents. American Diabetes Association. Pediatrics. 2000 Mar;105(3 Pt 1):671-80. doi: 10.1542/peds.105.3.671. No abstract available.
Background: PubMed 17015542SEARCH for Diabetes in Youth Study Group; Liese AD, D'Agostino RB Jr, Hamman RF, Kilgo PD, Lawrence JM, Liu LL, Loots B, Linder B, Marcovina S, Rodriguez B, Standiford D, Williams DE. The burden of diabetes mellitus among US youth: prevalence estimates from the SEARCH for Diabetes in Youth Study. Pediatrics. 2006 Oct;118(4):1510-8. doi: 10.1542/peds.2006-0690.

Related trials for Obesity

RecruitingObservational study
Endoscopic Sleeve Gastroplasty (ESG) Prospective Trial for Obesity (EGO-Trial)
Obesity
Active, not recruitingPhase 4
Effects of Sequential Therapy With Mexidol® (Intravenous) and Mexidol® FORTE 250 (Oral) on Functional Brain Activity Assessed by Functional Magnetic Resonance Imaging and Biochemical Parameters in Patients With Chronic Cerebral Ischemia: A Comparison of Patients With and Without Metabolic Disorders
Metabolic Abnormalities, Obesity & Overweight
Recruiting
Exercise Training and Vitamin D Metabolism
Obesity & Overweight, Vitamin D
Recruiting
Metabolic Health, Bones and Nuts During Weight Loss in Adults
Weight Loss, Bone Density
Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Maria L Evia-Viscarra, M.D. principal investigator

Hospital Regional de Alta Especialidad del Bajio

Edel R Rodea-Montero, Statistician study chair

Hospital Regional de Alta Especialidad del Bajio

Evelia Apolinar-Jiménez, Nutrition study chair

Hospital Regional de Alta Especialidad del Bajio

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Metformin in people with Obesity, run by Hospital Regional de Alta Especialidad del Bajio at 2 sites in Mexico.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Apr 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 23 Apr 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Adiponectin (time frame: baseline and 3 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01410604, which also lists 38 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2012.