Metabolic SyndromePhase 4NCT00926341
The Effects of Peroxisome Proliferators Activated Receptor-Gamma (PPAR-γ) Agonists on Certain Biochemical and Inflammatory Markers in Metabolic Syndrome
A Phase 4 study testing Pioglitazone and Telmisartan in people with Metabolic Syndrome, run by Aligarh Muslim University at 1 site in India.
Trial summary
Metabolic syndrome, labeled as the world's latest epidemic, is the force behind the global epidemic of Type 2 Diabetes Mellitus and Cardio Vascular Diseases. This emerging epidemic is an important public health problem for South Asians in their homeland and worldwide. Read more about this study
- Who is it for?
- Ages 30 to 70 years
- Conditions the study is for
- Metabolic Syndrome
- What is being tested?
- Pioglitazone and Telmisartan
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteIndia
- Study dates
- Oct 2006to Sep 2008
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 30 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with at least 3 out of 5 criteria of metabolic syndrome of NCEP-ATP III (Asian-Pacific) guideline:
- Waist circumference of > 90 cm in men or > 80 cm in women;
- Serum triglycerides of >= 150 mg/dl;
- High-density lipoprotein-cholesterol (HDL-C) levels of < 40 mg/dl in men and < 50 mg/dl in women;
- Fasting glucose of 6.1/ m.mol (≥l00 mg/dl)
- Systolic blood pressure > = 130 mmHg or Diastolic blood pressure >= 85 mmHg or OR on anti-hypertensive therapy
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- Ability to perform all tasks related to glycemic control and risk factor management.
- Written informed consent.
- Between 30 and 70 years of age of either sex.
Who cannot join
- Concomitant use of ACE inhibitor or ARB in the last 3 months. Or angioedema with ACE I / ARB or uncontrolled hypertension (SBP >=160 mmHg and/or DBP >=100 mmHg) or known case of secondary hypertension.
- Patients already taking any thiazolidinediones or having contraindications for the same.
- Class III or IV heart failure
- Renal dysfunction as defined by serum creatinine > 130umol/L (> 2.0 mg/dl)
- Concomitant use of statin or fenofibrate.
- Hepatic dysfunction as defined by SGPT (ALT)> 3 times the upper limit of normal
Show all 10Show fewer
- Taking Anti-obesity medications/metformin
- History of drug or alcohol dependency within six months.
- History of active malignancy, chronic,inflammatory disorder, or chronic infections which would interfere with protocol completion.
- Use of systemic glucocorticosteroids/aspirin/anti-inflammatory drugs.
Trial locations and contacts
1 site in 1 country.
India1 site
Department of Medicine, J.N.Medical,College, AMU,Aligarh
Aligarh, Uttar Pradesh, 202002
About this study
Official title: A Study on the Effects of Peroxisome Proliferators Activated Receptor-γ Agonists on Certain Biochemical and Inflammatory Markers in Patients With Metabolic Syndrome
Metabolic syndrome, labeled as the world's latest epidemic, is the force behind the global epidemic of Type 2 Diabetes Mellitus and Cardio Vascular Diseases. This emerging epidemic is an important public health problem for South Asians in their homeland and worldwide.
Pharmacological therapy is a critical step in the management of patients with metabolic syndrome. In general, treatment for metabolic syndrome, that targets all or most of the components of metabolic syndrome is either deficient or non-existent. The study presented here is the pioneering work in the management of metabolic syndrome, the emerging global epidemic.
Read the detailed description
Our understanding of the metabolic syndrome has been improved by the discovery nuclear peroxisome proliferator-activated receptors (PPARs). PPAR-γ is a nuclear receptor that influences the expression of multiples gene involved in carbohydrate and lipid metabolism. At the crossroads of obesity, insulin resistance, and cardiovascular disease is the nuclear receptor PPAR-γ. At present, metabolic syndrome can be described as a 'PPAR-γ agonist resistance syndrome.' The modulation of PPAR-gamma activity is an interesting therapeutic approach to address multi-component metabolic syndrome and its consequent cardiovascular events.
Recent studies have indicated that in addition to anti diabetic properties, PPAR-γ agonists (TZD)-Pioglitazone, provides protection against atherosclerotic cardiovascular disease. Further, the identification of ARBs-Telmisartan and Irbesartan, as capable of activating PPAR - γ, has provided a novel approach in treating hypertension, insulin resistance, hyperlipidemia, and inflammation.
Emerging evidence suggests that PPAR-γ agonist: Thiazolidinediones (TZD)-Pioglitazone is an insulin sensitizer and modulator of metabolic syndrome, through its pleiotropic effects on vascular risk and have beneficial effects on systemic inflammatory markers. Despite the beneficial effects of full PPAR- agonists like the TZDs, recent evidence suggests that full PPAR- agonists are less than optimal agents in patients with metabolic syndrome. TZDs promote adipo-genesis and fluid retention, causing weight gain and precipitate congestive heart failure. The adverse effects of full PPAR- agonists like the TZDs have reinforced the need to identify additional therapies with insulin-sensitizing properties. The recent discovery that telmisartan, an angiotensin II type 1 receptor (AT1-R) blockers (ARBs), is uniquely capable of selective PPAR- -modulating activities, have the potential to treat both hemodynamic and biochemical features of insulin resistance and metabolic Syndrome.
- Conditions
- Metabolic Syndrome
- Being tested
- Pioglitazone, Telmisartan
- Keywords
- Metabolic syndrome, inflammatory markers, Thiazolidinediones, Angiotensin receptor blockers
- Medical subject headings
- Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PioglitazoneDrug
Tab. Pioglitazone-30 mg/day, oral, 24 weeks
TelmisartanDrug
Tab. Telmisartan- 40 mg/day, oral, 24 weeks
| Study group | Role | What they receive |
|---|---|---|
| Active control | No intervention | 1. Active Control: (n=20), intervention: no intervention |
| PIO arm | Active comparator | PIO arm (n=30), Pioglitazone 30 mg/day, given for 24 weeks. Receives: Drug: Pioglitazone |
| Telmi arm | Active comparator | Telmia arm (n=30): Tab. Telmisartan 40 mg/day given for 2 weeks. Receives: Drug: Telmisartan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Control of blood pressure and decline in triglycerides level
Measured: 24 weeks
Secondary outcomes (1)
Improvement in Inflammatory markers Hs-CRP, TNF-alpha, IL-6 and visceral obesity
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2009 (estimated)
- Study startOct 2006
- Primary completionJun 2008
- Study completionSep 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Metabolic SyndromeStudies 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
- None (open label)
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aligarh Muslim University
- Sponsor type
- University, hospital or other
- Investigators
- Shahzad F HAQUE, MBBS.MD, Principal investigator, Department of medicine,JNMC, AMU, ALIGARH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00926341
- Sponsor's protocol ID
- SFH-CASR-FMD-06
- Status last verified
- Jun 2009
- First submitted
- 22 Jun 2009
- Last updated
- 24 Jun 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
Szapary PO, Bloedon LT, Samaha FF, Duffy D, Wolfe ML, Soffer D, Reilly MP, Chittams J, Rader DJ. Effects of pioglitazone on lipoproteins, inflammatory markers, and adipokines in nondiabetic patients with metabolic syndrome. Arterioscler Thromb Vasc Biol. 2006 Jan;26(1):182-8. doi: 10.1161/01.ATV.0000195790.24531.4f. Epub 2005 Nov 10.
PubMed 16284192
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study on the Effects of Peroxisome Proliferators Activated Receptor-γ Agonists on Certain Biochemical and Inflammatory Markers in Patients With Metabolic Syndrome
- ClinicalTrials.gov ID
- NCT00926341
- Acronym / sponsor ID
- SFH-CASR-FMD-06
- Conditions
- Metabolic Syndrome
- Keywords
- Metabolic syndrome, inflammatory markers, Thiazolidinediones, Angiotensin receptor blockers
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Aligarh Muslim UniversityUniversity, hospital or other
- Study start
- Oct 2006
- Primary completion
- Jun 2008 (actual)
- Study completion
- Sep 2008 (actual)
- First posted
- 23 Jun 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Metabolic syndrome, labeled as the world's latest epidemic, is the force behind the global epidemic of Type 2 Diabetes Mellitus and Cardio Vascular Diseases. This emerging epidemic is an important public health problem for South Asians in their homeland and worldwide.
Pharmacological therapy is a critical step in the management of patients with metabolic syndrome. In general, treatment for metabolic syndrome, that targets all or most of the components of metabolic syndrome is either deficient or non-existent. The study presented here is the pioneering work in the management of metabolic syndrome, the emerging global epidemic.
Detailed description
Our understanding of the metabolic syndrome has been improved by the discovery nuclear peroxisome proliferator-activated receptors (PPARs). PPAR-γ is a nuclear receptor that influences the expression of multiples gene involved in carbohydrate and lipid metabolism. At the crossroads of obesity, insulin resistance, and cardiovascular disease is the nuclear receptor PPAR-γ. At present, metabolic syndrome can be described as a 'PPAR-γ agonist resistance syndrome.' The modulation of PPAR-gamma activity is an interesting therapeutic approach to address multi-component metabolic syndrome and its consequent cardiovascular events.
Recent studies have indicated that in addition to anti diabetic properties, PPAR-γ agonists (TZD)-Pioglitazone, provides protection against atherosclerotic cardiovascular disease. Further, the identification of ARBs-Telmisartan and Irbesartan, as capable of activating PPAR - γ, has provided a novel approach in treating hypertension, insulin resistance, hyperlipidemia, and inflammation.
Emerging evidence suggests that PPAR-γ agonist: Thiazolidinediones (TZD)-Pioglitazone is an insulin sensitizer and modulator of metabolic syndrome, through its pleiotropic effects on vascular risk and have beneficial effects on systemic inflammatory markers. Despite the beneficial effects of full PPAR- agonists like the TZDs, recent evidence suggests that full PPAR- agonists are less than optimal agents in patients with metabolic syndrome. TZDs promote adipo-genesis and fluid retention, causing weight gain and precipitate congestive heart failure. The adverse effects of full PPAR- agonists like the TZDs have reinforced the need to identify additional therapies with insulin-sensitizing properties. The recent discovery that telmisartan, an angiotensin II type 1 receptor (AT1-R) blockers (ARBs), is uniquely capable of selective PPAR- -modulating activities, have the potential to treat both hemodynamic and biochemical features of insulin resistance and metabolic Syndrome.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Active control | No intervention | –1. Active Control: (n=20), intervention: no intervention |
| PIO arm | Active comparator | Drug: PioglitazonePIO arm (n=30), Pioglitazone 30 mg/day, given for 24 weeks. |
| Telmi arm | Active comparator | Drug: TelmisartanTelmia arm (n=30): Tab. Telmisartan 40 mg/day given for 2 weeks. |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patients with at least 3 out of 5 criteria of metabolic syndrome of NCEP-ATP III (Asian-Pacific) guideline:
- Ability to perform all tasks related to glycemic control and risk factor management.
- Written informed consent.
- Between 30 and 70 years of age of either sex.
Key exclusion criteria (10 listed)
- Concomitant use of ACE inhibitor or ARB in the last 3 months. Or angioedema with ACE I / ARB or uncontrolled hypertension (SBP >=160 mmHg and/or DBP >=100 mmHg) or known case of secondary hypertension.
- Patients already taking any thiazolidinediones or having contraindications for the same.
- Class III or IV heart failure
- Renal dysfunction as defined by serum creatinine > 130umol/L (> 2.0 mg/dl)
- Concomitant use of statin or fenofibrate.
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 |
|---|---|---|
| PioglitazoneTab. Pioglitazone-30 mg/day, oral, 24 weeks | Drug | PIO arm |
| TelmisartanTab. Telmisartan- 40 mg/day, oral, 24 weeks | Drug | Telmi arm |
Primary outcome
Control of blood pressure and decline in triglycerides level
Time frame: 24 weeks
1 secondary outcome
Improvement in Inflammatory markers Hs-CRP, TNF-alpha, IL-6 and visceral obesity
Time frame: 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2009.
- Background: PubMed 16284192Szapary PO, Bloedon LT, Samaha FF, Duffy D, Wolfe ML, Soffer D, Reilly MP, Chittams J, Rader DJ. Effects of pioglitazone on lipoproteins, inflammatory markers, and adipokines in nondiabetic patients with metabolic syndrome. Arterioscler Thromb Vasc Biol. 2006 Jan;26(1):182-8. doi: 10.1161/01.ATV.0000195790.24531.4f. Epub 2005 Nov 10.
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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.
Shahzad F HAQUE, MBBS.MD principal investigator
Department of medicine,JNMC, AMU, ALIGARH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Pioglitazone and Telmisartan in people with Metabolic Syndrome, run by Aligarh Muslim University at 1 site in India.
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 9 inclusion and 10 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 24 Jun 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Control of blood pressure and decline in triglycerides level (time frame: 24 weeks). 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 NCT00926341, which also lists 1 linked publication.
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 24 Jun 2009.