Effect of Meal Frequency on Insulin Resistance in Subjects With Type 2 Diabetes
This study has been completed.
Sponsor:
Institute for Clinical and Experimental Medicine
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
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Purpose
Aims and priorities of the project The purpose of this study is to
- 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.
- 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).
- 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:
- Type 2 diabetes for more than 1 year
- Treatment of T2D. Oral hypoglycemic agents stable for the last 3 months
- HbA1c ≥4.2 and ≤10.5% (IFCC)
- Agek 30-70 years
- Body Mass Index (kg/m2) between 27 and 50
- Willingness to follow both different dietary regimens
- The patient has at least 3 of the symptoms of the metabolic syndrome
Exclusion Criteria:
- Alcoholism or drug abuse
- Pregnancy, lactation
- Nonstable medication for diabetes, hypertension or dyslipidemia in the last 3 months
- Diagnosis of type 1 diabetes
- Weight loss or weight gain in the last 3 months (> 5% of the total body weight)
- Cardiostimulant
Contacts and Locations
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
| 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 May 22, 2013