Comparison of Hypoglycaemic Regimens During Ramadan Fasting in Type 2 Diabetes

June 19, 2012 updated by: Dr Saira Burney, Services Hospital, Lahore

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

161

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Diet and lifestyle measures alone.
Type 2 diabetic subjects on lifestyle counselling as part of diabetes treatment would continue as such during Ramadan. They would receive acarbose on one day to be followed by CGMS for a 24 hour period
Drug: Acarbose
Tab.Acarbose 50mg BD for one day in addition to existing medication to 10% of patients in each treatment arm.
Other Names:
  • *Tab.Glucobay 50mg (Bayer).
Other: Diet and lifestyle
Patients would follow a 1200 KCal Ramadan diet plan, and exercise for 30 minutes per day
ACTIVE_COMPARATOR: Metformin monotherapy
Type 2 diabetics on biguanide treatment.
Drug: Acarbose
Tab.Acarbose 50mg BD for one day in addition to existing medication to 10% of patients in each treatment arm.
Other Names:
  • *Tab.Glucobay 50mg (Bayer).
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
Other Names:
  • Tablets Glucophage (Merck)
ACTIVE_COMPARATOR: Metformin + Sulphonylurea.
Type 2 diabetics on dual oral hypoglycaemics-metformin and glimepiride.
Drug: Acarbose
Tab.Acarbose 50mg BD for one day in addition to existing medication to 10% of patients in each treatment arm.
Other Names:
  • *Tab.Glucobay 50mg (Bayer).
Other: Diet and lifestyle
Patients would follow a 1200 KCal Ramadan diet plan, and exercise for 30 minutes per day
Drug: Metformin/ Glimepride
Metformin 500mg and Glimepride 1mg in a combination tablet. Dosage frequency BD
Other Names:
  • Tablet Getformin 1/500 (Getz Pharma)
ACTIVE_COMPARATOR: Metformin + Sitagliptin
Type 2 diabetics managed on dual oral hypoglycaemic therapies: metformin and sitagliptin.
Drug: Acarbose
Tab.Acarbose 50mg BD for one day in addition to existing medication to 10% of patients in each treatment arm.
Other Names:
  • *Tab.Glucobay 50mg (Bayer).
Other: Diet and lifestyle
Patients would follow a 1200 KCal Ramadan diet plan, and exercise for 30 minutes per day
Drug: Metformin/Sitagliptin
Metformin 500 and sitagliptin 50mg in a combination tablet,dosage frequency BD.
Other Names:
  • Tab.TreviaMet 50/500 (Getz Pharma)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Services Hospital, Lahore

Investigators

  • Principal Investigator: Dr Khadija Irfan, MBBS,FCPS, Services Hospital.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2011

Primary Completion (ACTUAL)

September 1, 2011

Study Completion (ACTUAL)

September 1, 2011

Study Registration Dates

First Submitted

March 19, 2012

First Submitted That Met QC Criteria

June 19, 2012

First Posted (ESTIMATE)

June 20, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

June 20, 2012

Last Update Submitted That Met QC Criteria

June 19, 2012

Last Verified

June 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RT2011

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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