Comparison of Hypoglycaemic Regimens During Ramadan Fasting in Type 2 Diabetes

Diabetes, Type 2 Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01624116
• Other study ID #: RT2011
• Status: Completed
• Phase: N/A
• First received: March 19, 2012
• Last updated: June 19, 2012
• Start date: August 2011
• Est. completion date: September 2011

Study information

• Verified date: June 2012
• Source: Services Hospital, Lahore
• Contact: n/a
• Is FDA regulated: No
• Health authority: Pakistan: Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 161
• Est. completion date: September 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Diabetes, Type 2

Intervention

Drug:
• Acarbose
Tab.Acarbose 50mg BD for one day in addition to existing medication to 10% of patients in each treatment arm.

Other:
• Diet and lifestyle
Patients would follow a 1200 KCal Ramadan diet plan, and exercise for 30 minutes per day

Drug:
• Metformin
Patients on metformin monotherapy prior to Ramadan will continue on it, in the same dose
• Metformin/ Glimepride
Metformin 500mg and Glimepride 1mg in a combination tablet. Dosage frequency BD
• Metformin/Sitagliptin
Metformin 500 and sitagliptin 50mg in a combination tablet,dosage frequency BD.

Locations

Country	Name	City	State
Pakistan	Endocrinology Unit & Diabetes Management Centre, Services Hospital.	Lahore

Sponsors (1)

Lead Sponsor	Collaborator
Services Hospital, Lahore

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in body weight and fructosamine levels during Ramadan fasting.	Change in body weight and fructosamine levels from baseline to end of Ramadan.	28 days (Average duration of Ramadan fasting)	No
Secondary	Change in fasting lipid profile from baseline to end of Ramadan.	Change in fasting lipid profile from baseline to end of Ramadan.	28 days(average duration of Ramadan)	No
Secondary	Change in ghrelin levels from baseline to end of Ramadan.	Change in ghrelin levels from baseline to end of Ramadan.	28days (average duration of Ramadan)	No
Secondary	Change in renal profile from baseline to end of Ramadan	Change in renal profile from baseline to end of Ramadan.	28 days(average duration of Ramadan)	No