Comparison of Hypoglycaemic Regimens During Ramadan Fasting in Type 2 Diabetes

Services Hospital, Lahore161 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

161

Conditions

Diabetes, Type 2

Interventions

AcarboseDRUG

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

Diet and lifestyleOTHER

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

MetforminDRUG

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

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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 (1)

Endocrinology Unit & Diabetes Management Centre, Services Hospital.

Lahore, Pakistan

Outcomes

Primary Outcomes

Change in body weight and fructosamine levels during Ramadan fasting.

Change in body weight and fructosamine levels from baseline to end of Ramadan.

Time frame: 28 days (Average duration of Ramadan fasting)

Secondary Outcomes

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

Time frame: 28 days(average duration of Ramadan)

Change in ghrelin levels from baseline to end of Ramadan.

Time frame: 28days (average duration of Ramadan)

Change in renal profile from baseline to end of Ramadan

Change in renal profile from baseline to end of Ramadan.

Time frame: 28 days(average duration of Ramadan)

Data from ClinicalTrials.gov

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