NCT01277471

Brief Summary

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

  1. 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. 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
54

participants targeted

Target at P25-P50 for not_applicable diabetes-mellitus-type-2

Timeline
Completed

Started Dec 2010

Shorter than P25 for not_applicable diabetes-mellitus-type-2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2010

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 6, 2011

Completed
11 days until next milestone

First Posted

Study publicly available on registry

January 17, 2011

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2011

Completed
Last Updated

April 6, 2012

Status Verified

April 1, 2012

Enrollment Period

10 months

First QC Date

January 6, 2011

Last Update Submit

April 4, 2012

Conditions

Diabetes Mellitus, Type 2

Keywords

meal frequencytype two diabetes

Outcome Measures

Primary Outcomes (1)

  • Change in Insulin Resistance

    Insulin Resistance measured by hyperinsulinemic isoglycemic clamp

    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.

Secondary Outcomes (6)

  • hepatic fat content

    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.

  • Insulin Secretion

    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.

  • insulin sensitivity

    Insulin secretion will be measured at weeks 0, 12 and 24.

  • Fatty acid composition in serum phospholipids

    Weeks 0,12 and 24

  • Gastrointestinal peptides

    Weeks 0, 12 and 24

  • +1 more secondary outcomes

Study Arms (2)

Arm A: 6 and 2 meals/day

EXPERIMENTAL

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)

Arm B: 2 and 6 meals/day

ACTIVE COMPARATOR

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

Interventions

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

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

Arm A: 6 and 2 meals/day
6 meals/day followed by 2 meals/dayBEHAVIORAL

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)

Arm B: 2 and 6 meals/day

Eligibility Criteria

Age30 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute for Clinical and Experimental Medicine

Prague, 140 21, Czechia

Location

Related Publications (1)

  • Kahleova H, Belinova L, Malinska H, Oliyarnyk O, Trnovska J, Skop V, Kazdova L, Dezortova M, Hajek M, Tura A, Hill M, Pelikanova T. Eating two larger meals a day (breakfast and lunch) is more effective than six smaller meals in a reduced-energy regimen for patients with type 2 diabetes: a randomised crossover study. Diabetologia. 2014 Aug;57(8):1552-60. doi: 10.1007/s00125-014-3253-5. Epub 2014 May 18.

    PMID: 24838678DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Terezie Pelikanova, Prof., MD

    Institute for Clinical and Experimental Medicine

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

January 6, 2011

First Posted

January 17, 2011

Study Start

December 1, 2010

Primary Completion

October 1, 2011

Study Completion

October 1, 2011

Last Updated

April 6, 2012

Record last verified: 2012-04

Locations

CZ(1)