Effects of Low- or High-glycemic Index Diets on Metabolic and Inflammatory Responses in Diabetics

NCT ID: NCT02383784

Last Updated: 2015-03-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-03-31

Study Completion Date

2007-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Background/Aims: Verify the effects of glycemic index (GI) on body composition, and on inflammatory and metabolic markers concentrations. Methods: Eighteen type 2 diabetics, (aged 42.4 + 5.1 years, BMI 29.2 + 4.8 kg.m-2) were randomly allocated to low GI (LGI) or high GI (HGI) groups. High or low GI meals were provided in the laboratory twice a day during 30 consecutive days. The other meals were consumed under free living condition and subjects were instructed to select foods presenting GI values corresponding to the allocated group. Body composition (body mass index, body fat percentage, waist circumference and waist-hip ratio), and inflammatory markers concentrations (interleukin-6, tumor necrosis factor-alpha, high molecular weight adiponectin, ultra-sensitive C-reactive protein and fibrinogen) and metabolic markers (glucose, insulin, total cholesterol, HDL cholesterol, free fatty acids, triglycerides and fructosamine) were assessed at baseline and after intervention. Food intake was monitored during the study. The criterion for statistical significance was P\<0.05.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Type 2 Diabetes Mellitus

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Low-GI diet

Low glycemic index diet

Group Type EXPERIMENTAL

Low GI index diet

Intervention Type DIETARY_SUPPLEMENT

Low glycemic index diet

High-GI diet

High glycemic index diet

Group Type EXPERIMENTAL

High GI diet

Intervention Type DIETARY_SUPPLEMENT

High glycemic index diet

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Low GI index diet

Low glycemic index diet

Intervention Type DIETARY_SUPPLEMENT

High GI diet

High glycemic index diet

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Type 2 diabetes mellitus
* Level of physical activity light to moderate
* Use of sulfonylureas or biguanides oral hypoglycemic drugs
* Stable medications for the previous 3 months

Exclusion Criteria

* Cardiovascular, renal, or liver disease
* Treatment for cancer
* Smokers
* Daily consumption of \> 50g/day of alcohol
* Pregnant, lactating, postmenopausal women,
* Hormone replacement therapy
* Recent change (last three months) in the level of physical activity or diet
* Weight instability (\> 3 kg in the previous three months),
* Therapeutic diet
* Allergies, test foods intolerance
* Use of drugs affecting body metabolism and/or food intake.
Minimum Eligible Age

20 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.

OTHER_GOV

Sponsor Role collaborator

Fundação de Amparo à Pesquisa do estado de Minas Gerais

OTHER

Sponsor Role collaborator

Federal University of Vicosa

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Dr Junia Maria Geraldo Gomes

MSc

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Metabolism and body composition laboratory, Federal University of Vicosa

Viçosa, Minas Gerais, Brazil

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Brazil

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

40501156099

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Glycemic Index and Brain Function
NCT01064778 COMPLETED NA
PROTeIn-rich Meals to Control Glucose
NCT06382480 RECRUITING NA