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
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