To study levels of calcium, phosphorous and vitamin in body fluids before and after a 12 weeks course of pioglitazone, an anti diabetic agent, in pateints with diabetes
- Conditions
- Health Condition 1: null- type 2 diabetes
- Registration Number
- CTRI/2012/04/002597
- Lead Sponsor
- RSSDI
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Other (Terminated)
- Sex
- Not specified
- Target Recruitment
- 30
Patients attending diabetic clinic or endocrine out patient department (OPD) services of SSKM Hospital and IPGMER will be considered. Patients of type 2 diabetes not controlled (fasting sugar >110, Post prandial > 180 or HbA1C >6.5) on medical nutrition therapy and metformin would be undertaken for the study
1)Patients with very poorly controlled sugars i.e. HbA1C more than 8 will not be enrolled since glycosuria is associated with hypercaiciuria and control of glycemic status with pioglitazone can decrease calcium excretion and confound results
2)Patients taking insulin and/or other anti-diabetic drugs will be excluded. Patients on ACE inhibitors and diuretics will be excluded as will patients having blood pressures above 180systolic or diastolic above 110 mm Hg
3)Also patients with associated disorders like primary hyperparathyroidism, chronic kidney disease, liver disease, any chronic illness, malignancy, chronic drug use like anti-epileptic agents, oral contraceptive pills, steroids which are likely to interfere with vitamin-D metabolism will be excluded.
4)Patients with pregnancy would be excluded. Patients on calcium or vitamin-D supplementation would also be excluded.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1) effect on urinary calcium and phosphate excretion <br/ ><br>2) effect on serum vitamin D and 1,25 vitamin D levelsTimepoint: 1) effect on urinary calcium and phosphate excretion <br/ ><br>2) effect on serum vitamin D and 1,25 vitamin D levels
- Secondary Outcome Measures
Name Time Method effect on glycemic controlTimepoint: 3 months