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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
161

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Services Hospital, Lahore

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2011

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2011

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2011

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 19, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 19, 2012

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 20, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 20, 2012

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 19, 2012

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • RT2011

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