NCT00883038

Brief Summary

The aim of the study is to evaluate the effect of experimental (vegetarian) diet compared to conventional diet with similar caloric restriction on insulin resistance, body weight and body composition in type 2 diabetic patients after 3 month diet program and additional 3 month diet program combined with intensive exercise. Hypothesis: Greater improvement in insulin resistance, greater weight loss without compromising the body composition (subjects will lose fat preferentially to lean body mass) and differences in the fatty tissue metabolism will be found in the experimental (vegetarian) group compared to the control (conventional diet) group despite the similar advise on caloric restriction in both diets. The differences between the two groups will increase after an intensive physical exercise program.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
70

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jul 2008

Shorter than P25 for phase_1

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

July 1, 2008

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

July 15, 2008

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2008

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2009

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 17, 2009

Completed
Last Updated

April 17, 2009

Status Verified

April 1, 2009

Enrollment Period

4 months

First QC Date

July 15, 2008

Last Update Submit

April 15, 2009

Conditions

Insulin Resistance

Keywords

insulin resistancevegetarian diet

Outcome Measures

Primary Outcomes (1)

  • Insulin resistance

    6 months

Secondary Outcomes (1)

  • Visceral to subcutaneous fatty tissue ratio

    6 months

Study Arms (2)

Active Comparator

ACTIVE COMPARATOR

Diabetic diet following the DNSG guidelines

Other: diabetic diet following the DNSG guidelines

Experimental

EXPERIMENTAL

Low-fat vegetarian diet

Other: low-fat vegetarian diet

Interventions

diabetic diet following the DNSG guidelinesOTHER

The DNSG diet consists of 15-20% protein, ≤7% saturated fat, 60-70% carbohydrate and monounsaturated fats, cholesterol ≤200 mg/day, fiber content 20-30g/day.

Active Comparator
low-fat vegetarian dietOTHER

The low-fat vegetarian diet (\~10% of energy from fat, 15% protein, and 75% carbohydrate, fiber content 40-50 g/day) consists of vegetables, fruits, grains, legumes and small amounts of nuts. Participants will be asked to avoid animal products and added fats and to favor low-glycemic index foods, such as beans and green vegetables.

Experimental

Eligibility Criteria

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

You may qualify if:

  • Individuals with type 2 diabetes as defined by the criteria of the American Diabetes Association and recognized by WHO, Expert Committee on the Diagnosis and Classification of Diabetes Mellitus (19,20)
  • Concurrent T2 DM therapy: The use of oral hypoglycemic medication stable for the last 3 months
  • HbA1c ≥ 4 and ≤ 9.0 % (IFCC) \~ ≥ 6.0 and ≤ 11 % (DCCT)
  • Men and women who are 30 to 70 years of age
  • Body Mass Index (kg/m2) between 25 and 53
  • Informed Consent: a signed and dated written consent obtained from the subject before any procedures are performed
  • Willing to change dietary habits and to follow the prescribed diet and exercise program

You may not qualify if:

  • Current alcohol or drug abuse
  • Pregnancy, lactating
  • Unstable medical status
  • Diagnosis of Type 1 diabetes mellitus
  • Significant weight gain or loss (defined as ≥ 10% of total body weight) within the past 3 months prior to screening.
  • Pacemaker or metal in the body.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute for Clinical and Experimental Medicine

Prague, Czechia

Location

Related Publications (2)

  • Kahleova H, Tonstad S, Rosmus J, Fisar P, Mari A, Hill M, Pelikanova T. The effect of a vegetarian versus conventional hypocaloric diet on serum concentrations of persistent organic pollutants in patients with type 2 diabetes. Nutr Metab Cardiovasc Dis. 2016 May;26(5):430-8. doi: 10.1016/j.numecd.2016.01.008. Epub 2016 Jan 28.

    PMID: 27107842DERIVED

  • Kahleova H, Matoulek M, Malinska H, Oliyarnik O, Kazdova L, Neskudla T, Skoch A, Hajek M, Hill M, Kahle M, Pelikanova T. Vegetarian diet improves insulin resistance and oxidative stress markers more than conventional diet in subjects with Type 2 diabetes. Diabet Med. 2011 May;28(5):549-59. doi: 10.1111/j.1464-5491.2010.03209.x.

    PMID: 21480966DERIVED

MeSH Terms

Conditions

Insulin Resistance

Condition Hierarchy (Ancestors)

HyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Terezie Pelikanova, MD, PhD

    Head of the Diabetes Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

July 15, 2008

First Posted

April 17, 2009

Study Start

July 1, 2008

Primary Completion

November 1, 2008

Study Completion

March 1, 2009

Last Updated

April 17, 2009

Record last verified: 2009-04

Locations

CZ(1)