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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hana Kahleova, Institute for Clinical and Experimental Medicine
ClinicalTrials.gov Identifier:
NCT01277471
First received: January 6, 2011
Last updated: April 4, 2012
Last verified: April 2012
  Purpose

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.


Condition Intervention
Diabetes Mellitus, Type 2
Behavioral: Meal frequency (6 meals vs. 2 meals/day)
Behavioral: 6 meals/day followed by 2 meals/day

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effect of Meal Frequency on Insulin Resistance, Insulin Secretion, and Hepatic Fat Content in Subjects With Type 2 Diabetes

Resource links provided by NLM:


Further study details as provided by Institute for Clinical and Experimental Medicine:

Primary Outcome Measures:
  • Change in Insulin Resistance [ Time Frame: Insulin resistance will be measured at weeks 0, 12 and 24. Change from baseline to 12 weeks and from week 12 to week 24 will be assessed. ] [ Designated as safety issue: No ]
    Insulin Resistance measured by hyperinsulinemic isoglycemic clamp


Secondary Outcome Measures:
  • hepatic fat content [ Time Frame: Hepatic fat content will be measured at weeks 0, 12 and 24. Change from baseline to 12 weeks and from week 12 to week 24 will be assessed. ] [ Designated as safety issue: No ]
    hepatic fat content measured by magnetic resonance spectroscopy

  • Insulin Secretion [ Time Frame: Insulin secretion will be measured at weeks 0, 12 and 24. Change from baseline to 12 weeks and from week 12 to week 24 will be assessed. ] [ Designated as safety issue: No ]
    Insulin secretion measured by meal test (standard breakfast)

  • insulin sensitivity [ Time Frame: Insulin secretion will be measured at weeks 0, 12 and 24. ] [ Designated as safety issue: No ]
    Insulin sensitivity will be measured using the isoglycemic hyperinsulinemic clamp.

  • Fatty acid composition in serum phospholipids [ Time Frame: Weeks 0,12 and 24 ] [ Designated as safety issue: No ]
    Fatty acid composition in serum phospholipids will be measured by gas liquid chromatography.

  • Gastrointestinal peptides [ Time Frame: Weeks 0, 12 and 24 ] [ Designated as safety issue: No ]
    Gastrointestinal peptides will be measured in response to a standard breakfast at times 0,30,60,120 and 180.

  • Oxidative stress markers and AGEs [ Time Frame: weeks 0,12 and 24 ] [ Designated as safety issue: No ]
    Oxidative stress markers and AGEs will be measured in a fasting state.


Enrollment: 54
Study Start Date: December 2010
Study Completion Date: October 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm A: 6 and 2 meals/day
6 meals/day for the first 12 weeks followed by 2 meals/day for additional 12 weeks at the same caloric restriction (-500 kcal/day)
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)
Active Comparator: Arm B: 2 and 6 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)
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)

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   30 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Type 2 diabetes for more than 1 year
  2. Treatment of T2D. Oral hypoglycemic agents stable for the last 3 months
  3. HbA1c ≥4.2 and ≤10.5% (IFCC)
  4. Agek 30-70 years
  5. Body Mass Index (kg/m2) between 27 and 50
  6. Willingness to follow both different dietary regimens
  7. The patient has at least 3 of the symptoms of the metabolic syndrome

Exclusion Criteria:

  1. Alcoholism or drug abuse
  2. Pregnancy, lactation
  3. Nonstable medication for diabetes, hypertension or dyslipidemia in the last 3 months
  4. Diagnosis of type 1 diabetes
  5. Weight loss or weight gain in the last 3 months (> 5% of the total body weight)
  6. Cardiostimulant
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01277471

Locations
Czech Republic
Institute for Clinical and Experimental Medicine
Prague, Czech Republic, 140 21
Sponsors and Collaborators
Institute for Clinical and Experimental Medicine
Investigators
Study Chair: Terezie Pelikanova, Prof., MD Institute for Clinical and Experimental Medicine
  More Information

No publications provided by Institute for Clinical and Experimental Medicine

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Hana Kahleova, Dr., Institute for Clinical and Experimental Medicine
ClinicalTrials.gov Identifier: NCT01277471     History of Changes
Other Study ID Numbers: 3142, NT/11238-4
Study First Received: January 6, 2011
Last Updated: April 4, 2012
Health Authority: Czech Republic: Ethics Committee

Keywords provided by Institute for Clinical and Experimental Medicine:
meal frequency
type two diabetes

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Insulin Resistance
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hyperinsulinism

ClinicalTrials.gov processed this record on September 18, 2014