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AzTrials

Pre DiabetesPREDICTNCT03558867

Personalised Medicine in Pre-diabetes and Early Type 2 Diabetes

A study testing Metformin + Healthy diet and Metformin + Personalized diet in people with Pre Diabetes and Type 2 Diabetes Mellitus, run by Garvan Institute of Medical Research at 1 site in Australia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 20 to 70 years
Conditions the study is for
Pre Diabetes, Type 2 Diabetes Mellitus
What is being tested?
Metformin + Healthy diet and Metformin + Personalized diet
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
138 participants
Where
1 siteAustralia
Study dates
5 Jun 2018to 23 Jul 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Prediabetes or early-stage type 2 diabetes according to the American Diabetes Association (2019) diagnostic criteria, with HbA1c ≤8.0% (64 mmol/mol).
  • Women of childbearing potential willing to take precautions to avoid pregnancy throughout the study and for 3 months after the end of treatment.
  • Willingness to provide written informed consent and willingness to participate and comply with the study.

Who cannot join

  • Females planning a pregnancy during the course of the research or 3 months after completion of the research project. Females who breastfeed.
  • 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 enzymes ALT and/or AST>3-times normal range limit.
  • Abnormal renal function as measured by (eGFR<45 mL/min/1.73m^2).
  • Individuals with a history of a psychological illness or condition that may interfere with the individual's ability to understand the requirements of the study.
  • Normo-glycaemia.
Show all 20Show fewer
  • HbA1c>8.0%
  • Cardiovascular event in the previous 6 months.
  • Current or recent (within 24 months) treatment with a glucose lowering medication (i.e. GLP-1 receptor agonist, SGLT2 inhibitor, thiazolidinedione, sulfonylurea, DPP-4 inhibitor or insulin).
  • Current or recent (within 3 months) treatment with metformin.
  • Treatment with an oral steroid.
  • Treatment with antibiotics in the last 3 months.
  • Treatment with immunosuppressive medications.
  • Treatment with medications known to interact with metformin, including cimetidine, vitamin K antagonists and nifedipine.
  • 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.
  • Any reason the Investigator believes the participant is not likely to be adherent to the study treatment and protocol, including non-adherence to run-in.

Trial locations and contacts

1 site in 1 country.

Australia1 site

  • Garvan Institute of Medical Research

    Sydney, New South Wales, 2010

Other trials in Australia

About this study

Official title: Personalised Medicine in Prediabetes - Towards Preventing Diabetes in Individuals at Risk

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.

Read the 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.

Being tested
Metformin + Healthy diet, Metformin + Personalized diet
Keywords
Pre Diabetes, Insulin resistance, Metformin, Gut microbiota, Type 2 Diabetes Mellitus
Medical subject headings
Glucose Intolerance, Diabetes Mellitus, Type 2, Insulin Resistance

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Metformin + Healthy dietDrug

    Also called Metformin + Healthy (low fat) diet

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

  • Metformin + Personalized dietDrug

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

Study groups in NCT03558867
Study groupRoleWhat they receive
Metformin + Healthy dietPlacebo comparatorMetformin (1500 mg/d, Extended Release) + Healthy, low fat diet
Receives: Drug: Metformin + Healthy diet
Metformin + Personalized dietActive comparatorMetformin (1500 mg/d, Extended Release) + Personalized diet based on an algorithm developed at the Weizmann Institute of Science (Zeevi et al, Cell 2015)
Receives: Drug: Metformin + Personalized diet

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Mean change in glycated haemoglobin (HbA1C, %) from baseline

    Difference in the reduction of HbA1C between the groups

    Measured: 6 months

Secondary outcomes (10)

  1. Total daily time of interstitial glucose levels below 7.8 mmol/L (140 mg/dL)

    Difference in the time (minutes) per day with interstitial glucose measured below 7.8 mmol/L (140 mg/dL) between the groups

    Measured: 6 months

  2. Glycaemic variability

    Difference in the glycaemic variability as derived from CGM between the groups

    Measured: 6 months

  3. Body weight

    Difference in the magnitude of weight loss between the groups

    Measured: 6 months

  4. Body fat mass

    Difference in body fat mass composition as assessed using dual-energy X-ray absorptiometry (DXA) between the groups

    Measured: 6 months

  5. Abdominal visceral fat volume

    Difference in the abdominal visceral fat volume as assessed using DXA between the groups

    Measured: 6 months

  6. Serum low-density lipoprotein (LDL)-cholesterol concentration

    Difference in serum LDL-cholesterol between the groups

    Measured: 6 months

  7. Serum high-density lipoprotein (HDL)-cholesterol concentration

    Difference in serum HDL-cholesterol concentration between the groups

    Measured: 6 months

  8. Serum triglycerides concentration

    Difference in serum triglycerides between the groups

    Measured: 6 months

  9. Blood pressure

    Difference in diastolic and systolic blood pressure between the groups

    Measured: 6 months

  10. Liver fat

    Difference in liver fat measured by the Fibroscan's controlled attenuation parameter (CAP) function between the groups

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Jun 2018
  2. Study start5 Jun 2018
  3. Primary completion15 Dec 2023
  4. Study completion23 Jul 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
138 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03558867
Sponsor's protocol ID
SVH 17/080
Acronym
PREDICT
Status last verified
Aug 2023
First submitted
5 Jun 2018
Last updated
5 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Htet TD, Godneva A, Liu Z, Chalmers E, Kolobkov D, Snaith JR, Richens R, Toth K, Danta M, Hng TM, Elinav E, Segal E, Greenfield JR, Samocha-Bonet D. Rationale and design of a randomised controlled trial testing the effect of personalised diet in individuals with pre-diabetes or type 2 diabetes mellitus treated with metformin. BMJ Open. 2020 Oct 10;10(10):e037859. doi: 10.1136/bmjopen-2020-037859.

    PubMed 33040003

Questions about this trial

What is this clinical trial studying?

A study testing Metformin + Healthy diet and Metformin + Personalized diet in people with Pre Diabetes and Type 2 Diabetes Mellitus, run by Garvan Institute of Medical Research at 1 site in Australia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean change in glycated haemoglobin (HbA1C, %) from baseline (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03558867, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2026.

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