Small frequent meals vs large infrequent meals in patients with diabetes

Phase 3

Conditions: Health Condition 1: E119- Type 2 diabetes mellitus without complications

Recruitment & Eligibility

Inclusion Criteria

1.Type 2 diabetes mellitus diagnosed as per the WHO criteria

2.Age between 20-65 years and belonging to either sex

3.Baseline HbA1c between 8.5-11.0%

Exclusion Criteria

1.Current treatment with insulin or insulin secretagogues

2.BMI more than 35kg/m2

3. Co-morbidities including Coronary artery disease, congestive heart failure and

other edematous states, chronic kidney disease Stage III or worse, chronic liver

disease, malignancy and chronic infections (such as tuberculosis), Hypo or

hyperthyroidism, malignancy, mental disorders

4.History of severe hypoglycemia or recurrent hypoglycemic episodes over last 2

months

5.Gastrointestinal disorders which preclude large meal intake

6.Unstable weight (increase or decrease of more than 3 kg over last 2 months

7.Anxiety disorders

8.Chronic alcohol intake, smoking or substance abuse

9.Drugs known to increase weight including antidepressants, antipsychotics,

antiepileptic drugs

10.Pregnant or lactating females

11.Shift workers

Primary Outcome Measures

Name	Time	Method
The effect of large infrequent meals(LIM) as compared to small frequent meals (SFM) <br/ ><br>on Glycemic parameters <br/ ><br>Timepoint: At end of 12 weeks and 24 weeks

Secondary Outcome Measures

Name	Time	Method
he effect of large infrequent meals(LIM) as compared to small frequent meals (SFM) <br/ ><br>on hormones <br/ ><br>Timepoint: At end of 12 weeks and 24 weeks;he effect of large infrequent meals(LIM) as compared to small frequent meals (SFM) <br/ ><br>on obesity <br/ ><br>Timepoint: At end of 12 weeks and 24 weeks;The effect of large infrequent meals(LIM) as compared to small frequent meals (SFM) on blood pressureTimepoint: At end of 12 weeks and 24 weeks;The effect of large infrequent meals(LIM) as compared to small frequent meals (SFM) on body compositionTimepoint: At end of 12 weeks and 24 weeks;The effect of large infrequent meals(LIM) as compared to small frequent meals (SFM) on hsCRPTimepoint: At end of 12 weeks and 24 weeks;The effect of large infrequent meals(LIM) as compared to small frequent meals (SFM) on lipid profileTimepoint: At end of 12 weeks and 24 weeks;The effect of large infrequent meals(LIM) as compared to small frequent meals (SFM)on HOMA IRTimepoint: At end of 12 weeks and 24 weeks