Hyperglycemia Clinical Trial
Official title:
The Effects of Meal Frequency on Glucose, Insulin, and Insulin Sensitivity in Women With Polycystic Ovary Syndrome (PCOS), People at High Risk for Developing Type 2 Diabetes and People With Type 2 Diabetes
Verified date | October 2017 |
Source | Harokopio University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 110 |
Est. completion date | September 2013 |
Est. primary completion date | September 2013 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | N/A and older |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Meropi Kontogianni | Agricultural University of Athens, National and Kapodistrian University of Athens |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Serum levels of glucose | Clinically useful change in serum glucose, defined as the restoration of glucose within normal limits during the 2-hour oral glucose tolerance test. | 6 months | |
Secondary | Serum levels of insulin | Clinically useful change in serum insulin, defined as the restoration of insulin within normal limits during the 2-hour oral glucose tolerance test. Improved insulin sensitivity. | 6 months | |
Secondary | HbA1c | Clinically useful change in HbA1c. | 6 months | |
Secondary | Lipidemic profile | Normal serum levels of cholesterol, High Density Lipoprotein (HDL), Low Density Lipoprotein (LDL) and Triglycerides. | 6 months |
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