Status:
COMPLETED
Effect of Meal Frequency on Glycemic Control of People at High Risk or Diagnosed With Diabetes
Lead Sponsor:
Meropi Kontogianni
Collaborating Sponsors:
Agricultural University of Athens
National and Kapodistrian University of Athens
Conditions:
Impaired Glucose Tolerance
Hyperinsulinism
Eligibility:
All Genders
Phase:
NA
Brief Summary
This study investigated any potential associations between two isocaloric diets with different meal frequency (3 meals versus 6 meals) and glycemic control in people at high diabetes risk (lean and ov...
Detailed Description
The effect of meal frequency on diabetes risk markers (e.g. glucose and insulin metabolism) has been studied in several studies so far, both in healthy individuals and in individuals being at risk for...
Eligibility Criteria
Inclusion
- The presence of type 2 diabetes was defined according to the current diagnostic criteria: (a) HbA1c ≥ 6.5%, (b) fasting plasma glucose ≥126 mg/dl (7.0 mmol/l). (c) 2-h plasma glucose ≥ 200 mg/dl (11.1 mmol/l) during an oral glucose tolerance test (OGTT), using a glucose load containing the equivalent of 75 g anhydrous glucose dissolved in water, or (d) a random plasma glucose ≥ 200 mg/dl (11.1 mmol/l) in patients with classic symptoms of hyperglycemia or hyperglycemic crisis.
- PCOS was defined according to the Rotterdam criteria (Rotterdam 2004) which include the presence of two or more of the following features: chronic oligoovulation or anovulation (fewer than six menstrual periods in the previous year), androgen excess (serum total testosterone \>70 mg/dl) and polycystic ovaries.
Exclusion
- Insulin sensitizers, i.e. metformin, contraceptives, steroids or any medications known to affect glucose, insulin or reproductive hormones for at least the last 6 months.
- Serious health problems like cardiovascular, liver or kidney diseases.
- Volunteers who were on diet, using medications affecting body mass or who had experienced a change in body weight ≥ 4.5 kg or a change in physical activity within the 6 months preceding the study onset were excluded.
Key Trial Info
Start Date :
October 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2013
Estimated Enrollment :
110 Patients enrolled
Trial Details
Trial ID
NCT02248272
Start Date
October 1 2011
End Date
September 1 2013
Last Update
October 4 2017
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