Condition category
Nutritional, Metabolic, Endocrine
Date applied
28/04/2006
Date assigned
28/04/2006
Last edited
28/04/2006
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr J.H. DeVries

ORCID ID

Contact details

Academic Medical Center
Department of Internal Medicine
F4-222
P.O. Box 22660
Amsterdam
1100 DD
Netherlands
+31 (0)20 5669111
j.h.devries@amc.uva.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

Diabecinn trial

Study hypothesis

The main objective of this randomized, placebo-controlled trial is to determine the effects of cinnamon extract on HbA1c and lipid profiles in type 2 diabetic patients.

Ethics approval

Ethics approval received from the local medical ethics committee

Study design

Randomised placebo-controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Diabetes Mellitus type 2 (DM type II)

Intervention

Diabecinn three times a day (tid) or placebo

Intervention type

Drug

Phase

Not Specified

Drug names

Diabecinn

Primary outcome measures

HbA1c.

Secondary outcome measures

1. Lipid profile
2. 6 point glucose profile
3. Hypoglycemia
4. Body weight
5. Free fatty acids
6. C-reactive protein (CRP)

Overall trial start date

01/05/2006

Overall trial end date

01/01/2007

Reason abandoned

Eligibility

Participant inclusion criteria

1. Type 2 diabetes patients
2. Age 35-70 years inclusive
3. HbA1c between 7 and 12% inclusive

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

120

Participant exclusion criteria

1. Pregnancy
2. Breast-feeding

Recruitment start date

01/05/2006

Recruitment end date

01/01/2007

Locations

Countries of recruitment

Netherlands

Trial participating centre

Academic Medical Center
Amsterdam
1100 DD
Netherlands

Sponsor information

Organisation

Academic Medical Center (AMC) (The Netherlands)

Sponsor details

P.O. Box 22660
Amsterdam
1100 DD
Netherlands

Sponsor type

University/education

Website

Funders

Funder type

Industry

Funder name

OTC Pharma

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes