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Personalised Medicine in Pre-diabetes and Early Type 2 Diabetes (PREDICT)

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ClinicalTrials.gov Identifier: NCT03558867
Recruitment Status : Recruiting
First Posted : June 15, 2018
Last Update Posted : June 15, 2018
Sponsor:
Collaborator:
Weizmann Institute of Science
Information provided by (Responsible Party):
Garvan Institute of Medical Research

Brief 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.


Condition or disease Intervention/treatment Phase
Pre Diabetes Type 2 Diabetes Mellitus Drug: Metformin + Healthy diet Drug: Metformin + Personalized diet Not Applicable

Detailed Description:

Prediabetes is common in overweight and obese individuals and, as with frank diabetes, it is a risk factor for cardiovascular disease, cognitive dysfunction, fatty liver, kidney, ophthalmic, renal and neuropathic disease, and cancer.

Effective management of dysglycemia in pre-diabetes and diabetes and prevention of diabetes in individuals at risk reduce the risk of organ damage and associated co-morbidities and improves the affected individuals' quality of life.

Metformin, an oral biguanide, is the first-line treatment of newly-diagnosed type 2 diabetes patients, and the pharmacological choice for preventing diabetes in individuals with pre-diabetes. Metformin is an ideal medication to initiate for diabetes prevention, due to its excellent safety profile (lack of hypoglycemia), neutral to marginally beneficial effect on body weight, evidence of cardio-protection, and low cost. However, clinical practice, backed by randomised clinical trials, suggests that metformin mono-therapy fails to achieve glycemic goals in 20-40% of type 2 diabetes patients and to prevent diabetes in approximately 20% of individuals with pre-diabetes.

While the mode of action of metformin is still being investigated, the liver and the gastrointestinal tract are thought to be the main targets responsible for the improvement in glycemia. An increasing body of evidence suggests that the gut microbiota play an important role in obesity, prediabetes and diabetes, and alterations in gut microbial composition have been described in individuals with type 2 diabetes and pre-diabetes. Interestingly, metformin-treated diabetes patients have a "healthier" gut microbial composition compared with treatment-naïve diabetes patients, and changes in gut microbial composition with metformin treatment has been suggested to contribute to the therapeutic effect of the medication.

Randomised, clinical study with parallel assignment and single-masking will be performed in treatment-naïve individuals with pre-diabetes or early type 2 diabetes (diagnosed in the last 6 months) aiming to compare the effect of metformin (extended release [XR]) 1500 mg/d administered with personalized diet (based on the Weizmann Institute Personalized Nutrition Project) or administered with a healthy (low fat) diet.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 264 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: Personalised Medicine in Prediabetes - Towards Preventing Diabetes in Individuals at Risk
Actual Study Start Date : June 5, 2018
Estimated Primary Completion Date : June 30, 2020
Estimated Study Completion Date : December 23, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prediabetes

Arm Intervention/treatment
Placebo Comparator: Metformin + Healthy diet
Metformin (1500 mg/d, Extended Release) + Healthy, low fat diet
Drug: Metformin + Healthy diet
Metformin (1500 mg/d, Extended Release) + Healthy, low fat diet
Other Name: Metformin + Healthy (low fat) diet

Active Comparator: Metformin + Personalized diet
Metformin (1500 mg/d, Extended Release) + Personalized diet based on an algorithm developed at the Weizmann Institute of Science (Zeevi et al, Cell 2015)
Drug: Metformin + Personalized diet
Metformin (1500 mg/d, Extended Release) + Algorithm-based personalized diet




Primary Outcome Measures :
  1. Mean change in HbA1C from the baseline level [ Time Frame: 6 months ]
    Difference of at least 0.4% in the reduction of HbA1C between the groups


Secondary Outcome Measures :
  1. Total daily time of interstitial glucose levels below 7.8 mmol/L (140 mg/dL) [ Time Frame: 6 months ]
    Total daily interstitial glucose levels by continuous glucose monitoring for periods of 14 days at baseline and at 6 months of treatment



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Ages Eligible for Study:   20 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • Individuals with pre-diabetes or newly-diagnosed (in the last 6 months) with type 2 diabetes, fulfilling the following criteria:

    o Impaired fasting glucose (IFG, plasma glucose [PG]- 5.6 - 6.9 mmol/L, ±0.2 mmol/L) and/or impaired glucose tolerance (IGT, 2-h PG 7.8 - 11.0 mmol/L, ±0.2 mmol/L) with or without elevated HbA1c (6.1 - 8.0 %).

  • Willingness to provide written informed consent and willingness to participate and comply with the study.

Exclusion Criteria:

  • Both male and female planning a pregnancy during the course of the research or 3 months after completion of the research project.
  • Patients with type 1 diabetes, chronically active inflammatory disease, neoplastic disease in the previous 3 years, chronic gastrointestinal disorders, including inflammatory bowel disease or celiac.
  • Liver disease (ALT and/or AST>3-times normal range limit).
  • Renal disease (eGFR<45 mL/min/1.73m2).
  • Patients with a history of a psychological illness or condition that may interfere with the patient's ability to understand the requirements of the study.
  • Normo-glycaemia.
  • Cardiovascular event in the previous 6 months.
  • Current or recent (within 24 months) treatment with a glucose lowering medication (i.e. metformin, GLP-1 receptor agonist, SGLT2 inhibitor, thiazolidinedione, sulfonylurea, DPP-4 inhibitor or insulin).
  • Treatment with an oral steroid.
  • Treatment with antibiotics/antifungal in the last 3 month.
  • Treatment with immunosuppressive medications.
  • Alcohol or substance abuse.
  • Participants who had received an investigational new drug within the last 6 months.
  • Participants involved in another clinical study.
  • Participants who actively lose weight.
  • Participants who had a bariatric surgery.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03558867


Contacts
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Contact: Dorit Samocha-Bonet, PhD +61292958309 d.samochabonet@garvan.org.au

Locations
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Australia, New South Wales
Garvan Institute of Medical Research Recruiting
Sydney, New South Wales, Australia, 2010
Contact: Jerry R Greenfield, MD, PhD    +61292958217    j.greenfield@garvan.org.au   
Contact: Dorit Samocha-Bonet, PhD    +61292958309    d.samochabonet@garvan.org.au   
Principal Investigator: Dorit Samocha-Bonet, PhD         
Principal Investigator: Jerry R Greenfield, MD, PhD         
Sponsors and Collaborators
Garvan Institute of Medical Research
Weizmann Institute of Science
Investigators
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Principal Investigator: Dorit Samocha-Bonet, PhD Garvan Institute of Medical Research
Principal Investigator: Jerry Greenfield, MD, PhD Garvan Institute of Medical Research
Principal Investigator: Eran Elinav, MD, PhD Weizmann Institute of Science
Principal Investigator: Eran Segal, PhD Weizmann Institute of Science

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Responsible Party: Garvan Institute of Medical Research
ClinicalTrials.gov Identifier: NCT03558867     History of Changes
Other Study ID Numbers: SVH 17/080
First Posted: June 15, 2018    Key Record Dates
Last Update Posted: June 15, 2018
Last Verified: June 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Garvan Institute of Medical Research:
Pre Diabetes
Insulin resistance
Metformin
Gut microbiota
Type 2 Diabetes Mellitus

Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Prediabetic State
Glucose Intolerance
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hyperglycemia
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs