Comparison of Hypoglycaemic Regimens During Ramadan Fasting in Type 2 Diabetes

NCT01624116 | Completed

• 1 other identifier: RT2011
• Study Type: interventional
• Target: 161
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes, Type 2

Outcome Measures

Primary Outcomes (1)

• Change in body weight and fructosamine levels during Ramadan fasting.

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

  28 days (Average duration of Ramadan fasting)

Secondary Outcomes (3)

• 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.

  28days (average duration of Ramadan)

• Change in renal profile from baseline to end of Ramadan

  28 days(average duration of Ramadan)

Study Arms (4)

Diet and lifestyle measures alone.

ACTIVE COMPARATOR

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; Other: Diet and lifestyle

Metformin monotherapy

ACTIVE COMPARATOR

Type 2 diabetics on biguanide treatment.

Drug: Acarbose; Other: Diet and lifestyle; Drug: Metformin

Metformin + Sulphonylurea.

ACTIVE COMPARATOR

Type 2 diabetics on dual oral hypoglycaemics-metformin and glimepiride.

Drug: Acarbose; Other: Diet and lifestyle; Drug: Metformin/ Glimepride

Metformin + Sitagliptin

ACTIVE COMPARATOR

Type 2 diabetics managed on dual oral hypoglycaemic therapies: metformin and sitagliptin.

Drug: Acarbose; Other: Diet and lifestyle; Drug: Metformin/Sitagliptin

Interventions

Acarbose DRUG

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

Also known as: *Tab.Glucobay 50mg (Bayer).

Diet and lifestyle measures alone.; Metformin + Sitagliptin; Metformin + Sulphonylurea.; Metformin monotherapy

Diet and lifestyle OTHER

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

Diet and lifestyle measures alone.; Metformin + Sitagliptin; Metformin + Sulphonylurea.; Metformin monotherapy

Metformin DRUG

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

Also known as: Tablets Glucophage (Merck)

Metformin monotherapy

Metformin/ Glimepride DRUG

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

Also known as: Tablet Getformin 1/500 (Getz Pharma)

Metformin + Sulphonylurea.

Metformin/Sitagliptin DRUG

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

Also known as: Tab.TreviaMet 50/500 (Getz Pharma)

Metformin + Sitagliptin

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• HbA1c 6.5-9.5%.
• Type 2 diabetics on two or less oral hypoglycaemic agents.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Services Hospital, Lahore: lead

Study Sites (1)

Endocrinology Unit & Diabetes Management Centre, Services Hospital.

Lahore, Pakistan

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Acarbose; Diet; Metformin; glimepiride; Sitagliptin Phosphate, Metformin Hydrochloride Drug Combination

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Trisaccharides; Oligosaccharides; Polysaccharides; Carbohydrates; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Biguanides; Guanidines; Amidines; Organic Chemicals; Sitagliptin Phosphate; Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrazines; Drug Combinations; Pharmaceutical Preparations

Study Officials

• Dr Khadija Irfan, MBBS,FCPS

  Services Hospital.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Registrar, Endocrinology Unit & Diabetes Management Centre, Services Institute of Medical Sciences,Lahore,Pakistan.

Study Record Dates

• First Submitted: March 19, 2012
• First Posted: June 20, 2012
• Study Start: August 1, 2011
• Primary Completion: September 1, 2011
• Study Completion: September 1, 2011
• Last Updated: June 20, 2012

Record last verified: 2012-06

Locations

PA (1)