Effect of MEDiterranean Diet on the microBIOME of Individuals With Type 2 Diabetes

NCT04403217 | Unknown

• 1 other identifier: MEDBIOME
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Dysbiosis of gut microbiota is associated with the pathophysiology of type 2 diabetes. Mediterranean diet has been indicated as a dietary pattern that promote the integrity of gut barrier and that has positive impact in the metabolic control of subjects with type 2 diabetes. This is a 12-week, single-arm clinical study that aims to evaluate if the effect of Mediterranean diet in metabolic control of these subjects is mediated by gut microbiota. Subjects will receive personalized nutrition counseling where Mediterranean diet will be promoted.

Conditions

Type 2 Diabetes

Keywords

Gut microbiota; Mediterranean diet; Type 2 diabetes

Outcome Measures

Primary Outcomes (7)

• Changes in intestinal microbiota from baseline to visit 2 and 3

  Bacterial DNA will be extracted from fecal samples. 16SRNA gene will be sequenced by next-generation sequencing (NGS). All the identified bacterial phyla, genus and species will be expressed in percentage

  1-week post run-in period (baseline), 4-week post Mediterranean diet intervention (visit 2) and 12-week post Mediterranean diet intervention (visit 3)

• Changes in HbA1c levels (percent) from baseline to visit 2 and 3

  1-week post run-in period (baseline), 4-week post Mediterranean diet intervention (visit 2), 12-week post Mediterranean diet intervention (visit 3)

• Changes in HOMA-IR from baseline to visit 2 and 3

  1-week post run-in period (baseline), 4-week post Mediterranean diet intervention (visit 2), 12-week post Mediterranean diet intervention (visit 3)

• Changes in HOMA-B (percent) from baseline to visit 2 and 3

  1-week post run-in period (baseline), 4-week post Mediterranean diet intervention (visit 2), 12-week post Mediterranean diet intervention (visit 3)

• Changes in HOMA-S (percent) from baseline to visit 2 and 3

  1-week post run-in period (baseline), 4-week post Mediterranean diet intervention (visit 2), 12-week post Mediterranean diet intervention (visit 3)

• Changes in fasting capillary blood glucose (mg/dL) from baseline to visit 2 and 3

  1-week post run-in period (baseline), 4-week post Mediterranean diet intervention (visit 2), 12-week post Mediterranean diet intervention (visit 3)

• Changes in fasting insulin (μU/mL) levels from baseline to visit 2 and 3

  1-week post run-in period (baseline), 4-week post Mediterranean diet intervention (visit 2), 12-week post Mediterranean diet intervention (visit 3)

Secondary Outcomes (9)

• Changes in diet quality from baseline to visit 3

  1-week post run-in period (baseline), 12-week post Mediterranean diet intervention (visit 3)

• Changes in food intake from baseline to visit 2 and 3

  1-week post run-in period (baseline), 4-week post Mediterranean diet intervention (visit 2), 12-week post Mediterranean diet intervention (visit 3)

• Changes in fasting serum total cholesterol (mg/dL) from baseline to visit 2 and 3

  1-week post run-in period (baseline), 4-week post Mediterranean diet intervention (visit 2), 12-week post Mediterranean diet intervention (visit 3)

• Changes in fasting serum high-density lipoprotein (HDL) (mg/dL) cholesterol from baseline to visit 2 and 3

  1-week post run-in period (baseline), 4-week post Mediterranean diet intervention (visit 2), 12-week post Mediterranean diet intervention (visit 3)

• Changes in fasting serum low-density lipoprotein (LDL) (mg/dL) cholesterol from baseline to visit 2 and 3

  1-week post run-in period (baseline), 4-week post Mediterranean diet intervention (visit 2), 12-week post Mediterranean diet intervention (visit 3)

Study Arms (1)

Individualized structured dietary plan based on MD

EXPERIMENTAL

Participants will follow an individualized structured dietary plan based on Mediterranean diet for 12 weeks

Other: Individualized structured dietary plan based on MD

Interventions

Individualized structured dietary plan based on MD OTHER

Participants will follow an individualized structured dietary plan based on Mediterranean diet for 12 weeks

Individualized structured dietary plan based on MD

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and women diagnosed with type 2 diabetes mellitus, according to the American Diabetes Association criteria;
• Ages 40-80 years;
• Non-smoker;
• Willing and able to provide written informed consent.

You may not qualify if:

• Diabetes diagnosed before 40 years old;
• Changes in oral glycaemic-control medications in the last 3 months;
• Subjects with HbA1c levels under 6.4% or above 10%;
• Subjects under insulinotherapy;
• Subjects under corticotherapy;
• Subjects with triglycerides levels above 4.52 nmol/L (400 mg/dL);
• Intake of antibiotics in the last 12 weeks;
• Subjects with a diagnosis of any digestive disease including functional bowel disorders such as IBS.

Sponsors & Collaborators

• Universidade Nova de Lisboa: lead

Study Sites (1)

NOVA Medical School|Faculdade de Ciências Médicas, Universidade NOVA de Lisboa

Lisbon, 1169-056, Portugal

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Central Study Contacts

Conceição Calhau

CONTACT

+351218803000; ccalhau@nms.unl.pt

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 20, 2020
• First Posted: May 27, 2020
• Study Start: April 1, 2019
• Primary Completion: July 31, 2021
• Study Completion: September 30, 2021
• Last Updated: May 27, 2020

Record last verified: 2020-05

Locations

PT (1)