Condition category
Nutritional, Metabolic, Endocrine
Date applied
19/10/2016
Date assigned
24/10/2016
Last edited
24/10/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Type 2 diabetes mellitus (T2DM) is a growing problem worldwide. People with T2DM have difficulty controlling their blood sugar (glucose) as they do not produce enough insulin to function properly (insulin deficiency), or that the body’s cells don’t react to insulin as they should do (insulin resistance). One of the most important ways of treating T2DM is through lifestyle changes, such as eating more healthily and exercising more. Nutritional supplements may be a good way of improving health in people with diabetes. The aim of this study is to find out whether supplements containing vitamin D, omega 3 or both can help patients better control their blood sugar levels.

Who can participate?
Patients aged between 25 and 55 who are type 2 diabetes.

What does the study involve?
Participants are randomly allocated to one of two groups. Those in the first group take three gelcaps (gel capsules) containing omega 3 supplements to take daily at meal times for 24 weeks. Those in the second group receive three gelcaps containing vitamin D supplements to take daily at meal times for 24 weeks. Those in the third group take three gelcaps containing vitamin D and three containing omega 3, daily at mealtimes for 24 weeks. Those in the fourth group take gelcaps containing cornstarch, which acts as a placebo (dummy pill) daily at mealtimes for 24 weeks. At the start of the study and then after 24 weeks, participants in all groups have their height, weight and diet assessed as well as providing a blood sample to test for blood sugar and fat levels.

What are the possible benefits and risks of participating?
Participants benefit from receiving information about their health free of charge, as well as possibly benefiting from the supplements they are taking. All supplements used in the study are available commercially and are safe to use so there are no known risks involved with participating. There is a small risk of pain or bruising from blood tests.

Where is the study run from?
The study is run by Universidad Autónoma del Estado de México and takes place in nine health centres (Mexico)

When is the study starting and how long is it expected to run for?
September 2015 to April 2018

Who is funding the study?
Consejo Nacional de Ciencia y Tecnología (Mexico)

Who is the main contact?
Dr Roxana Valdes-Ramos
rvaldesr@uaemex.mx

Trial website

Contact information

Type

Scientific

Primary contact

Dr Roxana Valdes-Ramos

ORCID ID

http://orcid.org/0000-0003-0093-886X

Contact details

Paseo Tollocan esq. Jesús Carranza
Col. Moderna de la Curz
Toluca
50180
Mexico

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

UAEM 212946

Study information

Scientific title

Effect of omega-3 fatty acid supplementation and vitamin D on the immuno-inflammatory process in patients with type 2 diabetes mellitus in Mexico

Acronym

Study hypothesis

1. A higher concentration of plasma polyunsaturated fatty acid and vitamin D will result in a better antiinflammatory profile in patients with type 2 diabetes mellitus
2. Type 2 diabetes mellitus patients supplemented with polyunsaturated fatty acids and vitamin D will have a better antiinflammatory profile in comparison with patients supplemented with polyunsaturated fatty acids of vitamin D

Ethics approval

Ethics and Research Committes of the Faculty of Medicine of the Universidad Autónoma del Estado de México, 31/01/2013

Study design

Placebo-controlled cluster randomised trial

Primary study design

Interventional

Secondary study design

Cluster randomised trial

Trial setting

Other

Trial type

Prevention

Patient information sheet

Condition

Type 2 Diabetes Mellitus

Intervention

Participating health clinics are randomised to one of four groups.

Group 1: Participants receive three gelcaps (Vitamin D-3 General Nutrition Centers™) daily, to be consumed one per meal time, with a total of 3300mg of fatty acids as follows: EPA 765 mg and DHA 240 mg per capsule.

Group 2: Participants receive three gelcaps (Fish Oil 1000 General Nutrition Centers™) daily, to be consumed one per meal time, with a total of 3000 IU of vitamin D3, each containing Cholecalciferol (equivalent to 1000 IU of Vitamin D3) 0.250mg.

Group 3: Participants receive three gelcaps (Vitamin D-3 General Nutrition Centers™) daily, to be consumed one per meal time, with a total of 3300mg of fatty acids as follows: EPA 765 mg and DHA 240 mg per capsule, and three gelcaps (Fish Oil 1000 General Nutrition Centers™) daily, to be consumed one per meal time, with a total of 3000 IU of vitamin D3, each containing Cholecalciferol (equivalent to 1000 IU of Vitamin D3) 0.250mg. That is one capsule of each supplement per meal time for a total of six per day.

Group 4: Participants receive three capsules filled with cornstarch per day, to be consumed one per meal time.

Once the patients were assigned to the supplement groups, they were called to attend their clinic for the baseline evaluation and given their four-week supplements and their subsequent appointment. At every four-week appointment, patients underwent a 24-food recall, the two adherence tests and received their next four-week supplement flasks. The treatment lasted 24 weeks, at the time when they were given their last appointment for final evaluation.

Intervention type

Supplement

Phase

Drug names

Primary outcome measures

1. Glucose (Cat. GL1611), glycosylated haemoglobin (Cat.HA3830A), total cholesterol (Cat. CHO215), HDL-cholesterol (Cat. CH3811A), LDL (Cat. CH3811B) & triacylglycerides (Cat. Tr213) are assessed using an ultrasensitive colorimetric method in an automated Selectra II equipment, with commercial RANDOX™ reactants. VLDL was calculated with the Friedwald equation (Friedwald et.al. 1972). All measurements were done at baseline and 24 weeks
2. Plasma fatty acids are measured using chromatography and methylation at baseline and 24 weeks
3. Vitamin D and insulin are measured using a commercial ELISA kit from R&D Systems (Cat. 51081) assay at baseline and 24 weeks
4. Cytokines are assessed using Milliplex Human Citokine Five Plex (Cat. MPXHCYTO-60K-05) for TNFα, IFN-γ, IL-1β, IL4 and IL10 and the Milliplex Human Citokine One Plex (Cat. MPXHCYTO-B-01) for TGF- β, at baseline and 24 weeks
5. Adipokines Adiponectin, Resistin and Leptin levels are assessed with the Milliplex Human Adipokine Magnetic Bead Panel (Cat.HADK1-61K-02 and Cat.HADK1-61K-01) at baseline and 24 weeks

Secondary outcome measures

1. Dietary intake is assessed through 24-hour dietary recall at baseline and every four weeks until the final evaluation at 24 weeks
2. Anthropometry (weight, height, BMI) is assessed with a portable stadiometer and weighing scale at baseline and 24 weeks
3. Treatment adherence is assessed with the Morinksey-Green and Haynes-Sackett tests every four weeks from baseline to week 24

Overall trial start date

01/01/2014

Overall trial end date

30/12/2016

Reason abandoned

Eligibility

Participant inclusion criteria

1. Diagnosed type 2 diabetes mellitus
2. Age between 25 and 55 years
3. BMI ≥ 29.9
4. With no other chronic pathology
5. No insulin treatment
6. HOMA ≥ 2.4

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

120 patients divided into four groups

Participant exclusion criteria

1. Pregnancy or lactation
2. Non-mixed Mexican origin (native or immigrants)
3. Lack of data from measurements

Recruitment start date

01/03/2015

Recruitment end date

30/09/2015

Locations

Countries of recruitment

Mexico

Trial participating centre

Faculty of Medicine, Universidad Autónoma del Estado de México
Paseo Tollocan esq. Jesús Carranza Col. Moderna de la Curz
Toluca
50180
Mexico

Sponsor information

Organisation

Universidad Autonoma del Estado de Mexico

Sponsor details

Instituto Literario 100
Col. Centro
Toluca
50000
Mexico

Sponsor type

University/education

Website

www.uaemex.mx

Funders

Funder type

Government

Funder name

Consejo Nacional de Ciencia y Tecnología (CONACyT)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication in a peer reviewed journal.

IPD Sharing plan:
The datasets generated during and/or analysed during the current study are/will be available upon request from Roxana Valdes-Ramos, DSc (Principal Investigator) rvaldesr@uaemex.mx

Intention to publish date

30/12/2017

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes