NCT00145093

Brief Summary

The purpose of this study is to determine whether chromium (yeast), is effective in improving glycaemic control and insulin resistance.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at below P25 for phase_3 diabetes-mellitus-type-2

Timeline
Completed

Started Aug 2004

Shorter than P25 for phase_3 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

August 1, 2004

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2005

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

September 2, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 5, 2005

Completed
Last Updated

November 22, 2005

Status Verified

September 1, 2005

First QC Date

September 2, 2005

Last Update Submit

November 21, 2005

Conditions

Diabetes Mellitus, Type 2

Keywords

Diabetes Mellitus, Type 2ChromiumSaccharomyces cerevisiae

Outcome Measures

Primary Outcomes (1)

  • To determine the effect of Baker's yeast treatment on glycemicic control and insulin resistance when given in combination with oral blood glucose lowering therapy to patients with type 2 diabetes mellitus

Secondary Outcomes (1)

  • To determine the effect of Baker's yeast treatment on serum lipids, blood pressure, body fat percentage and BMI when given in combination with oral blood glucose lowering therapy to patients with type 2 diabetes mellitus

Interventions

Baker's yeast (Bio Chromium)DRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • type 2 diabetes with haemoglobin A1c level between 7 and 8.5% at the last visit
  • treated with oral blood glucose lowering therapy, which has not been changed for the last three months.

You may not qualify if:

  • pregnant women; women trying to become pregnant
  • patients with a serum creatinine concentration over 150 micromol/l in men and 120 micromol/l in women, Cockcroft \< 50 ml/min
  • hepatic enzyme levels (ALAT) over 90 U/l (2 x upper limit)
  • patients known with allergy or intolerance for yeast
  • patients currently taking chromium supplements
  • patients treated with insulin.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

General Practice

Heerde, Netherlands

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Henk JG Bilo, MD PhD FRCP

    Isala clinics, medical research foundation

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 2, 2005

First Posted

September 5, 2005

Study Start

August 1, 2004

Study Completion

February 1, 2005

Last Updated

November 22, 2005

Record last verified: 2005-09

Locations

NL(1)