Condition category
Nutritional, Metabolic, Endocrine
Date applied
06/07/2016
Date assigned
26/07/2016
Last edited
26/07/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Obesity is a growing concern worldwide, which can lead to serious health problems such as diabetes, heart disease and even cancer. Many obese patients experience changes to their metabolism (chemical process in the body to maintain life), which increases their risk of developing cardiovascular disease (disease of the heart and/or blood vessels). Metabolically healthy obesity (MHO) is a type of obesity in which there are no disruptions to metabolism. Currently, there are many discussions about whether MHO patients have a lower risk of developing diabetes or cardiovascular disease and if weight-loss can help further lower this risk. The Mediterranean diet is considered to be one of the healthiest diets worldwide, and particularly effective at helping prevent obesity. In addition, exercise has been shown to be extremely effective at helping people to lose weight as well as protecting against death and disease. The aim of this study is to find out whether weight-loss in MHO patients can help to prevent diabetes and cardiovascular disease.

Who can participate?
Adults aged between 35 and 55 with MHO.

What does the study involve?
Participants are randomly allocated to one of two groups. Participants in the first group consume a Mediterranean diet for two years. This diet involves using olive oil as the main source of dietary fat, increasing consumption of fruits, vegetables and fish, reducing consumption of red meat, and cutting out dairy products, sugary drinks and confectionery. Participants are also encouraged to practice daily exercise, which involves walking on average for 150 minutes every week for the two years of the study. Participants in the second group continue as normal for the duration of the study. Participants in both groups have their blood sugar measured at the start of the study and then after 3, 6, 12, 18 and 24 months in order to test for diabetes. Additionally, participants provide further blood samples to test levels of chemicals in the body which are important for metabolism and have their weight and blood pressure measured.

What are the possible benefits and risks of participating?
If participants continue the healthy lifestyle they adopt during this study, then it is likely to have long term benefits for their heart health. There are no notable risks involved with participating in this study.

Where is the study run from?
1. Regional Universitary Hospital of Malaga (Spain)
2. Hospital Virgen de la Victoria (Spain)

When is the study starting and how long is it expected to run for?
January 2012 to June 2016

Who is funding the study?
1. Instituto de Salud Carlos III (Spain)
2. FEDER Funds (Spain)

Who is the main contact?
Dr Maria Rosa Bernal-Lopez
rosa.bernal@ibima.eu

Trial website

Contact information

Type

Scientific

Primary contact

Dr Maria Rosa Bernal-Lopez

ORCID ID

http://orcid.org/0000-0002-0238-0890

Contact details

Internal Medicine Department
Biomedical Institute of Malaga (IBIMA)
Regional University Hospital of Malaga (Carlos Haya Hospital)
Avda. Carlos Haya s/n
Málaga
29009
Spain
+34951290346
rosa.bernal@ibima.eu

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

HRM-MHO/12-01373

Study information

Scientific title

Cardiometabolic effect of weight loss in metabolically healthy obese subjects (MHO)

Acronym

Study hypothesis

The aim of this study is to investigate assess whether significant weight loss induces short-term metabolic benefits in metabolically healthy obese (MHO) individuals and whether the rate of weight loss influences the metabolic response to the intervention.

Ethics approval

Ethics approval by the institutional ethical committee (Comité Coordinador de Ética de la Investigación Biomédica de Andalucía), 20/04/2012, ref: 140402

Study design

Multi-centre randomized controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Obesity

Intervention

Participants are randomly allocated to one of two groups using a computer-generated sequence of random numbers.

Intervention group: Participants take up a Mediterranean diet for two years, which is based on the use of olive oil as the main source of visible fat and regular consumption of vegetables (≥2 servings / day), fruits (≥3 servings / day), legumes (≥3 servings / week) and fish (≥3 times a week), reducing the consumption of red meat or sausage (<2 times a week) and eliminating (or reducing to <1 time / week) the consumption of dairy products, sugary drinks and confectionery. The recommended diet provide a calorie deficit of 600 Kcal/day. Participants are also encouraged to practice daily exercise, with a minimum target walk an average of 150 minutes a week for the two year duration of the study.
Participants receive nine medical visits throughout the study (every three months during the first year, then every six months) by the specialist physician and a nurse visit every four weeks during the first semester and then every 3 months until the end of the study (16 visits throughout the study). Checkups include general hygiene and dietary recommendations and clinical assessment.

Control group: Participants receive a minimum of four medical consultations and four nursing visits annually, which may be extended at the discretion of the physician or nurse responsible according to the associated pathology presented by the patient, according to standard clinical practice in these cases will be made. Checkups include general recommendations on heart-healthy diet and exercise, and identical clinical and analytical assessments as in the experimental group. During nursing visits (individual, 10 minutes) participants receive written information about diet and exercise without specific individual recommendations.

Participants are followed up at 3, 6, 12, 18 and 24 months for the intervention group and at 12, 18 and 24 months in the control group.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measures

Type 2 diabetes and/or prediabetes incidence is determined by measuring:
1. Fasting plasma glucose levels at baseline, 3, 6, 12, 18 and 24 months
2. Oral glucose tolerance testat baseline, 12 and 24 months
3. Glycated hemoglobin (HbA1c) at baseline, 3, 6, 12, 18 and 24 months

Secondary outcome measures

1. Anthropometric variables are measured at baseline, 3, 6, 12, 18 and 24 months for the intervention group and at baseline, 12, 18 and 24 months in the control group.
1.1. Weight measured in kg on a scale
1.2. Waist circumfrence is measured in cm
1.3. BMI is calculated as the ratio between weight and height (kg/m2)
1.4. Blood pressure is measured using a validated automatic sphygmomanometer (OMRON M4-I) when the participant is in a sitting position.
2. Insulin resistance is calculated using the HOMA-IR index and proinsulin/insulin ratio at baseline, 12, 18 and 24 months
3. Serum lipid profile (HDL-cholesterol, LDL-cholesterol, Triglycerides) is measured using commercial equipment (Dimension®, Dade Behring, Germany) at baseline, 12, 18 and 24 months
4. Inflammatory parameters (leucocytes, fibrinogen, hs-CRP, IL-6, TNF-a) are measured using an Enzyme-Linked ImmunoSorbent Assay at baseline, 12, 18 and 24 months
5. Metabolic hormone (adiponectin and resistin) levels are measured using an Enzyme-Linked ImmunoSorbent Assay at baseline, 12, 18 and 24 months
6. Liver function is measured through serum liver function tests (AST, ALT, GGT) and Fatty Liver Index (FLI) at baseline, 12, 18 and 24 months

Overall trial start date

01/01/2012

Overall trial end date

30/06/2016

Reason abandoned

Eligibility

Participant inclusion criteria

1. Aged 35-55 years
2. Metabolically healthy obese (MHO)*
3. BMI between 30-45 kg/m2

*A participant is considered to have MHO status when meeting ≤1 of these four metabolic syndrome criteria: fasting plasma glucose ≥100 mg/dL, blood pressure ≥135/85 mmHg (or use of blood pressure-lowering agents), HDL-cholesterol ≤50 mg/dL, and triglycerides ≥150 mg/dL (or use of lipid-lowering therapies).

Participant type

Healthy volunteer

Age group

Adult

Gender

Both

Target number of participants

279

Participant exclusion criteria

1. Diabetes or impaired glucose tolerance
2. Hypertension
3. Pregnancy or planning to become pregnant during the study
4. Cardiovascular disease
5. Severe systemic disease (advanced organ failure, dementia, cancer)
6. Immobilized individuals
7. Alcohol or drug abuse
8. Severe psychiatric illness
9. Patients who self-initiated a program of physical activity or started a diet in the past three months
10. Weight loss ≥5 kg in the last 6 months of unknown cause

Recruitment start date

15/06/2013

Recruitment end date

15/04/2014

Locations

Countries of recruitment

Spain

Trial participating centre

Regional Universitary Hospital of Malaga
Avda. Hospital Civil s/n
Málaga
29010
Spain

Trial participating centre

Hospital Virgen de la Victoria
Campus de Teatinos s/n
Malaga
29010
Spain

Sponsor information

Organisation

Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud (FIMABIS)

Sponsor details

Avda. Jorge Luis Borges 15
Bloque 3
Planta 3ª
Málaga
29010
Spain
+34 951440260
robelopajiju@yahoo.es

Sponsor type

Research organisation

Website

Funders

Funder type

Government

Funder name

Instituto de Salud Carlos III

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

FEDER Funds

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer reviewed journal.

Intention to publish date

30/06/2017

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes