Effect of Meal Frequency on Glycemic Control of People at High Risk or Diagnosed With Diabetes (NCT02248272) | Clinical Trial Compass
CompletedNot Applicable
Effect of Meal Frequency on Glycemic Control of People at High Risk or Diagnosed With Diabetes
110 participantsStarted 2011-10
Plain-language 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 overweight/obese women with PCOS, individuals with hyperinsulinemia, individuals with impaired glucose tolerance) and diagnosed with diabetes.
Who can participate
SexALL
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Inclusion Criteria:
* 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 Criteria:
* 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.