Clinical trial NCT02248272: Effect of Meal Frequency on Glycemic Control of People at High Risk or Diagnosed With Diabetes
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Impaired Glucose Tolerance
Hyperinsulinism
Poor Glycemic Control
Hyperglycemia
Insulin Sensitivity
Keywords: Polycystic ovary syndrome
Type 2 Diabetes
Hyperinsulinemia
Meal frequency
Lead sponsor: Harokopio University
Sponsor class: OTHER
Collaborators: name: Agricultural University of Athens
name: National and Kapodistrian University of Athens
First posted: 2014-09-25
Enrollment: 110
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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 overweight/obese women with PCOS, individuals with hyperinsulinemia, individuals with impaired glucose tolerance) and diagnosed with diabetes.

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 diabetes mellitus, with or without concurrent weight loss. In addition, few studies have investigated the effect of different meal frequency on glycemic control in patients with diabetes mellitus under conditions of weight maintenance. However, the results regarding the ideal number of meals remain controversial.

To our best knowledge, there is no study available that has investigated the effect of meal frequency on glucose and insulin metabolism in lean and obese women with PCOS, in lean and obese individuals with hyperinsulinemia and impaired glucose tolerance, and in obese individuals with type 2 diabetes, independently of weight loss.

Eligibility criteria: 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.

Primary outcomes:
measure: Serum levels of glucose
timeFrame: 6 months
Secondary outcomes:
measure: Serum levels of insulin
timeFrame: 6 months
measure: HbA1c
timeFrame: 6 months
measure: Lipidemic profile
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
affiliation: Agricultural University of Athens
name: Aimilia Papakonstantinou, PhD
role: STUDY_DIRECTOR
affiliation: Harokopio University of Athens
name: Meropi Kontogianni, PhD
role: PRINCIPAL_INVESTIGATOR
References: