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Completed

NCT Number: NCT01624116

Comparison of Hypoglycaemic Regimens During Ramadan Fasting in Type 2 Diabetes

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.

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Key information

Conditions

Diabetes, Type 2 Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Endocrinology Unit & Diabetes Management Centre, Services Hospital.

Lahore, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Acarbose

Drug

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).

Diet and lifestyle

Other

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

metformin

Drug

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

Other names: Tablets Glucophage (Merck)

Metformin/ Glimepride

Drug

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

Other names: Tablet Getformin 1/500 (Getz Pharma)

Metformin/Sitagliptin

Drug

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

Other names: Tab.TreviaMet 50/500 (Getz Pharma)

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

Services Hospital, Lahore

Other Gov

Registry information

Official study 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

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Jun 20, 2012
Registry last updated
Jun 20, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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