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Personalised Medicine in Pre-diabetes and Early Type 2 Diabetes

NCT03558867 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 138

Last updated 2024-10-31

No results posted yet for this study

Summary

Prediabetes is a common condition in overweight individuals affecting approximately 35% of American adults and 30% of Australian adults. Like diabetes, prediabetes is a serious risk factor for cardiovascular disease, eye, kidney and liver disease, and some types of cancer.

Appropriate blood glucose control is crucial in preventing pre-diabetes complications and onset of diabetes, yet clinical practice, backed by randomised trials, reports that many patients treated with standard dietary guidelines or with the first-line treatment of diabetes patients, metformin, do not improve blood glucose control sufficiently.

The overarching goal of the present project is to improve the efficacy of metformin mono-therapy in pre-diabetes and early type 2 diabetes.

Conditions

Interventions

DRUG

Metformin + Healthy diet

Metformin (1500 mg/d, Extended Release) + Healthy, low fat diet

DRUG

Metformin + Personalized diet

Metformin (1500 mg/d, Extended Release) + Algorithm-based personalized diet

Sponsors & Collaborators

  • Weizmann Institute of Science

    collaborator OTHER

  • Garvan Institute of Medical Research

    lead OTHER

Principal Investigators

  • Dorit Samocha-Bonet, PhD · Garvan Institute of Medical Research

  • Jerry Greenfield, MD, PhD · Garvan Institute of Medical Research

  • Eran Elinav, MD, PhD · Weizmann Institute of Science

  • Eran Segal, PhD · Weizmann Institute of Science

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-06-05
Primary Completion
2023-12-15
Completion
2024-07-23

Countries

  • Australia

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03558867 on ClinicalTrials.gov