A Phase 4 interventional study of Pioglitazone and Telmisartan in Metabolic Syndrome, sponsored by Aligarh Muslim University. Completed at 1 site in India. Open to participants aged 30 Years to 70 Years. Per ClinicalTrials.gov, last updated 2009-06-24.
Sponsored by Aligarh Muslim University · Phase 4, Interventional, and Treatment
Among 15 studies testing pioglitazone in Metabolic Syndrome — none open to participants now, none under way, none of them phase 3. Pioglitazone · Metabolic Syndrome.
Among the 15 studies testing pioglitazone in Metabolic Syndrome, this one has the largest enrollment, is one of 2 that started in 2006, is one of 7 in phase 4, and was the 12th registered.
2,116 studies on the registry are indexed under Metabolic Syndrome; 347 are open to participants now.
This study's enrollment of 110 is above the median of 60 across 1,572 interventional studies indexed under Metabolic Syndrome.
Browse Metabolic Syndrome studies →None of the 15 studies testing pioglitazone in Metabolic Syndrome is open now.
Pioglitazone: first FDA approval 1999 (ACTOS), first EMA approval 2000. What it is approved for, and how studies give it, is on its page →
Of the 232 Metabolic Syndrome studies recruiting now, 68 (29%) set no upper age limit and 136 (59%) stop at 75 or younger; 20 take children under 18; 80 take healthy volunteers.
This study: 30 Years to 70 Years · all sexes · no healthy volunteers.
The full table on the hub →15 studies; the count open now beside each. This study's row is marked.
First in 2003; this study’s year is marked. 2 started in 2006.
Median enrollment 40 across the 15 interventional studies. Of the 14 that completed or were terminated, 10 (71%) have results posted.
None of the 15 has an industry lead sponsor. The 10 most frequent:
Aligarh Muslim University is the lead sponsor of 7 studies on the registry; 1 is open to participants now.
Aligarh Muslim University has 1 study filed under Metabolic Syndrome — fewer than ten, so there is no comparison to draw.
None of the studies under way reaches primary completion within a year.
Among the 15 studies testing pioglitazone in Metabolic Syndrome, from their registry updates:
Nothing recorded among them since 2026-09-25.
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.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Patients with at least 3 out of 5 criteria of metabolic syndrome of NCEP-ATP III (Asian-Pacific) guideline:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
1. Active Control: (n=20), intervention: no intervention
PIO arm (n=30), Pioglitazone 30 mg/day, given for 24 weeks.
Drug: Pioglitazone
Telmia arm (n=30): Tab. Telmisartan 40 mg/day given for 2 weeks.
Drug: Telmisartan
Tab. Pioglitazone-30 mg/day, oral, 24 weeks
Tab. Telmisartan- 40 mg/day, oral, 24 weeks
Control of blood pressure and decline in triglycerides level
Time frame: 24 weeks
Improvement in Inflammatory markers Hs-CRP, TNF-alpha, IL-6 and visceral obesity
Time frame: 24 weeks
This study is completed, as verified in Jun 2009. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Pioglitazone · Telmisartan
Aligarh Muslim University