MedTrace Logo

Effect of Meal Frequency on Insulin Resistance in Subjects With Type 2 Diabetes

NCT01277471 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 54

Last updated 2012-04-06

No results posted yet for this study

Summary

Aims and priorities of the project The purpose of this study is to

1. test the effect of frequency of meals (six vs. two meals daily with the same daily caloric restriction of -500 kcal/day) on insulin sensitivity, insulin secretion, and hepatic fat content.
2. characterize some of the mechanisms of action of different frequencies of meals (amount of visceral fat, hepatic fat content, serum concentrations of adipokines, gut hormones, oxidation stress markers).
3. test the ability of the participants to maintain hypocaloric diet on both regimens when educated and left to prepare their meals alone in comparison with those for whom all meals during the study will be provided.

It will be a randomized, crossover study, where 50 individuals with type 2 diabetes will change in a random order two regimens: six, and two meals a day. Each testing period will take three months.

Glucose and lipid metabolism and its regulation will be thoroughly tested at start, and after each 3-months-period (meal test, hyperinsulinemic isoglycemic clamp, indirect calorimetry, MRI scan of the liver, DXA scan, serum concentration determination of selected adipokines, gut hormones, and oxidation stress markers).

Hypothesis The investigators hypothesize that low plasma insulin levels (as achieved by periods of fasting) will reduce insulin resistance and hepatic lipid content. In contrast, frequent meals (and consequent higher plasma levels of insulin) will predispose to non-alcoholic fatty liver disease and insulin resistance. The investigators further hypothesize that the participants will increase their caloric intake with increased meal frequency (in spite of thorough education) when left to prepare their meals in comparison with those for whom all meals will be provided.

Conditions

  • Diabetes Mellitus, Type 2

Interventions

BEHAVIORAL

Meal frequency (6 meals vs. 2 meals/day)

6 meals/day for 12 weeks followed by 2 meals/day for 12 weeks at the same caloric restriction (-500 kcal/day)

BEHAVIORAL

6 meals/day followed by 2 meals/day

2 meals/day for the first 12 weeks followed by 6 meals/day for additional 12 weeks at the same caloric restriction (-500 kcal/day)

Sponsors & Collaborators

  • Institute for Clinical and Experimental Medicine

    lead OTHER_GOV

Principal Investigators

  • Terezie Pelikanova, Prof., MD · Institute for Clinical and Experimental Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
30 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-12-31
Primary Completion
2011-10-31
Completion
2011-10-31

Countries

  • Czechia

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01277471 on ClinicalTrials.gov