Comparison of Hypoglycaemic Regimens During Ramadan Fasting in Type 2 Diabetes

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01624116

Enrollment

161

Registered

2012-06-20

Start date

2011-08-31

Completion date

2011-09-30

Last updated

2012-06-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes, Type 2

Brief 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.

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.

Interventions

DRUGAcarbose

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

OTHERDiet and lifestyle

Patients would follow a 1200 KCal Ramadan diet plan, and exercise for 30 minutes per day

DRUGMetformin

Patients on metformin monotherapy prior to Ramadan will continue on it, in the same dose

DRUGMetformin/ Glimepride

Metformin 500mg and Glimepride 1mg in a combination tablet. Dosage frequency BD

DRUGMetformin/Sitagliptin

Metformin 500 and sitagliptin 50mg in a combination tablet,dosage frequency BD.

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Change in body weight and fructosamine levels during Ramadan fasting.	28 days (Average duration of Ramadan fasting)	Change in body weight and fructosamine levels from baseline to end of Ramadan.

Secondary

Measure	Time frame	Description
Change in fasting lipid profile from baseline to end of Ramadan.	28 days(average duration of Ramadan)	Change in fasting lipid profile from baseline to end of Ramadan.
Change in ghrelin levels from baseline to end of Ramadan.	28days (average duration of Ramadan)	Change in ghrelin levels from baseline to end of Ramadan.
Change in renal profile from baseline to end of Ramadan	28 days(average duration of Ramadan)	Change in renal profile from baseline to end of Ramadan.

Countries

Pakistan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026