Effect of Meal Frequency on Glycemic Control of People at High Risk or Diagnosed With Diabetes

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02248272
• Other study ID #: 8062
• Secondary ID: HUA
• Status: Completed
• Phase: N/A
• First received: September 22, 2014
• Last updated: October 2, 2017
• Start date: October 2011
• Est. completion date: September 2013

Study information

• Verified date: October 2017
• Source: Harokopio University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Glucose Intolerance
• Hyperglycemia
• Hyperinsulinism
• Hypersensitivity
• Impaired Glucose Tolerance
• Insulin Resistance
• Insulin Sensitivity
• Polycystic Ovary Syndrome
• Poor Glycemic Control

Intervention

Other:
• Isocaloric diet with 3 meals
Isocaloric diet with 3 meals in order to maintain volunteers' weight, tailored to individual energy needs, with the same macronutrient composition. The volunteers were free to choose the foods they used to consume before. However, in order to assist them to adapt to the different meal frequency, individualized instructions were given to all volunteers before their entry to the study. An example of a 7-day diet menu was prescribed for both diet programs and analytical food exchange lists of different food groups were also provided.
• Isocaloric diet with 6 meals
Isocaloric diet with 6 meals in order to maintain volunteers' weight, tailored to individual energy needs, with the same macronutrient composition. The volunteers were free to choose the foods they used to consume before. However, in order to assist them to adapt to the different meal frequency, individualized instructions were given to all volunteers before their entry to the study. An example of a 7-day diet menu was prescribed for both diet programs and analytical food exchange lists of different food groups were also provided.

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Meropi Kontogianni	Agricultural University of Athens, National and Kapodistrian University of Athens

Outcome

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