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Comparison of Hypoglycaemic Regimens During Ramadan Fasting in Type 2 Diabetes

Information source: Services Hospital, Lahore
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Diabetes, Type 2

Intervention: Acarbose (Drug); Diet and lifestyle (Other); Metformin (Drug); Metformin/ Glimepride (Drug); Metformin/Sitagliptin (Drug)

Phase: N/A

Status: Completed

Sponsored by: Services Hospital, Lahore

Official(s) and/or principal investigator(s):
Dr Khadija Irfan, MBBS,FCPS, Principal Investigator, Affiliation: Services Hospital.

Summary

Type 2 diabetic patients who fast during Ramadan experience swings in glycaemic control between hypoglycaemic troughs and hyperglycaemic spikes. Hence, the dual challenge in fasting diabetics is to identify which treatment modality leads to the most stable blood glucose levels during a fast and how to smooth out these excursions and reduce risks of fast to a minimum.

Clinical Details

Official title: A Comparison of Four Hypoglycaemic Regimens During Ramadan Fasting in Type 2 Diabetic Patients and the Effect of Add-On Acarbose on Glycaemic Excursions During Ramadan Fasting

Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Change in body weight and fructosamine levels during Ramadan fasting.

Secondary outcome:

Change in fasting lipid profile from baseline to end of Ramadan.

Change in ghrelin levels from baseline to end of Ramadan.

Change in renal profile from baseline to end of Ramadan

Detailed description: Study Objectives:

- To compare changes in clinical and metabolic parameters from baseline to the end of

four weeks fasting in Ramadan between four treatment arms:

- diet and lifestyle measures alone.

- metformin monotherapy.

- combination therapy with metformin + sulfonylurea.

- combination therapy with metformin + sitagliptin.

- To compare the 24 hour CGMS profile during Ramadan fasting in type 2 diabetic patients

before and after addition of acarbose to these pre-existing sub-maximal hypoglycaemic regimens.

Eligibility

Minimum age: N/A. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- HbA1c 6. 5-9. 5%.

- Type 2 diabetics on two or less oral hypoglycaemic agents.

Exclusion Criteria:

- Any contraindications either to fasting or to any of the trial medication.

- Pregnancy.

- Serum creatinine > 1. 4 mg/dl.

- Serum ALT > twice upper limit normal.

- History of pancreatitis, serum amylase > twice upper limit normal.

- History of intolerance to acarbose.

Locations and Contacts

Endocrinology Unit & Diabetes Management Centre, Services Hospital., Lahore, Pakistan
Additional Information

Starting date: August 2011
Last updated: June 19, 2012

Page last updated: August 23, 2015

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