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Type 2 Diabetes Treated With InsulinILIADNCT04957173

Intensive Lifestyle Intervention in Patients With Insulin-treated Type 2 Diabetes: a Pilot Project

A study testing Lifestyle intervention in people with Type 2 Diabetes Treated With Insulin, run by Centre hospitalier de l'Université de Montréal (CHUM).

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

This study is a pilot study carried out to assess the feasibility, safety and effectiveness of an intensive lifestyle intervention, implemented virtually by a multidisciplinary team, in patients living with advanced insulin-treated T2DM. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Type 2 Diabetes Treated With Insulin
What is being tested?
Lifestyle intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
No sites listed yet
Study dates
14 Oct 2021to 30 Jul 2023
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 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age 18 to 75, BMI 27 to 45 kg / m2
  • Diagnosed T2DM
  • Insulin-treated for a minimum of 5 years
  • Having a glycated hemoglobin <9.5% (HbA1c dating ≤3 months)
  • Having internet and telephone access to enable monitoring of the intervention and remote blood glucose monitoring
  • If treated with a glucagon like peptide-1 (GLP-1), must be on a stable dose for a minimum of 6 months
  • Having good autonomy in managing medication (including insulin) and preparing meals.

Who cannot join

  • A diagnosis of T2DM with a tendency to ketosis
  • A history of ketoacidosis associated with taking an SGLT2 inhibitor
  • Medical history of eating disorders
  • Severe hypoglycemia in the past year or decreased perception of hypoglycemia determined by Clarke's method with a score ≥ 4 (17)
  • A history of gastrointestinal tract surgery that alters the ability to absorb nutrients (weight loss surgery, short bowel, etc.) [cholecystectomy or appendectomy are not exclusion criteria]
  • A history of pancreatic insufficiency, advanced liver disease or liver transplant [Hepatic steatosis is not an exclusion criterion]
Show all 14Show fewer
  • Active cancer under treatment or a history of cancer with active treatment in the past year (basal cell carcinoma is not an exclusion criteria)
  • Daily fluid restriction
  • A pregnant / breastfeeding participant, wishing to be pregnant during the study period or having given birth less than one year before the start of the study
  • The presence of advanced complications of T2DM (renal failure with estimated glomerular filtration rate <30 ml / min / 1.73m2, proliferative diabetic retinopathy, severe neuropathy)
  • Drug or alcohol use in the past 12 months. Defined by more than 2 drinks per day or more 10 per week for women, and more than 3 drinks per day or more than 15 per week for men.
  • Advanced fragility (See the score which is in the recommendations of Diabetes Canada chapter elderly people)
  • A macrovascular episode (heart attack, stenting, coronary bypass surgery or stroke less than 6 months ago.
  • An active wound Additional to the inclusion/exclusion criterias, the PI will determine the inclusion of the participant to the study.

About this study

Official title: Intervention Intensive Sur le Mode de Vie Chez Les Patients Atteints d'obésité Avec un diabète de Type 2 avancé Insuline-traité : un Projet Pilote

This study is a pilot study carried out to assess the feasibility, safety and effectiveness of an intensive lifestyle intervention, implemented virtually by a multidisciplinary team, in patients living with advanced insulin-treated T2DM. This 24-week study will include 2 pre-intervention virtual visits and 15 virtual visits during the intervention.

Read the detailed description

The prevalence of type 2 diabetes (T2DM) has increased rapidly over the past decades. This chronic condition, strongly associated with abdominal obesity, leads to serious complications. Traditional recommendations for the management of T2DM mainly suggest the use of drugs to control blood sugar and the concomitant risk factors. However, this approach can be expensive and some therapies have significant side effects. Although programs aimed at improving lifestyle habits are essential in the management of T2DM, the implementation of these programs involves many challenges such as the need for patients to travel and access to a multidisciplinary team.

A few studies have recently proposed that one can induce remission of T2DM. Considering that this disease appears to be the result of metabolic stress induced by an excessive accumulation of fat in the internal organs, the reduction of this excess of lipids by a significant weight loss could reduce the metabolic stress and modify the progression of the disease. disease.

The implementation of a virtual lifestyle intervention could make it possible to follow up patients who do not have access to a multidisciplinary team nearby or who are unable to travel.

The objective of this project is to assess the feasibility of the nutritional intervention by measuring food intake, eating behaviors and factors facilitating or limiting adherence to the intervention. As well as to examine the effect of this intervention on weight loss and waist circumference; doses of insulin and other drugs to treat T2DM, dyslipidemia and high blood pressure; glycemic control and possible complications; eating behaviors and quality of life.

Being tested
Lifestyle intervention

What participants receive

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

  • Lifestyle interventionOther

    The intervention includes a total of 17 virtual meetings and aims to achieve a weight loss of 0.8 to 1% of the initial weight per week.

    This will include 3 successive phases:

    1. A significant calorie restriction (A minimum deficit of 800 kcal / day of their daily energy expenditure) for a period of 4 weeks;
    2. A moderate calorie restriction (minimum deficit of 500 kcal / day of their daily energy expenditure) for a period of 4 weeks;
    3. A maintenance phase of weight loss for 16 weeks.
    4. An optional phase of monthly follow-ups for a period of 3 months (no intervention)
Study groups in NCT04957173
Study groupRoleWhat they receive
Intensive lifestyle interventionOtherParticipants will undergo an intensive lifestyle intervention, implemented virtually by a medical team with expertise in the management of T2DM. This team will be made up of an endocrinologist, a nutritionist and a nurse.
Receives: Other: Lifestyle intervention

What is being measured

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

  1. The primary outcome of this study will be weight loss in the participants.

    Weeks 1 to 4: Target weight loss of 1% per week (on average) Weeks 5 to 8: Loss of 0.5% of target weight per week (on average) Weeks 9 to 24: Maintaining target weight

    Measured: 24 weeks

Timeline

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

  1. First posted12 Jul 2021
  2. Study start14 Oct 2021
  3. Primary completion30 Jul 2023
  4. Study completion30 Jul 2023

Why it stopped: Recruitment was difficult, and the investigator decided to close the study.

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
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04957173
Sponsor's protocol ID
ILIAD-CHUM
Acronym
ILIAD
Status last verified
Aug 2023
First submitted
23 Jun 2021
Last updated
5 Sep 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Sun CJ, Nguyen E, Prentki M, Rabasa-Lhoret R. The daunting task of recruiting insulin-treated patients living with type 2 diabetes mellitus for intensive lifestyle interventions. Diabetes Obes Metab. 2024 Aug;26(8):3486-3488. doi: 10.1111/dom.15688. Epub 2024 Jun 5. No abstract available.

    PubMed 38840460

Questions about this trial

What is this clinical trial studying?

A study testing Lifestyle intervention in people with Type 2 Diabetes Treated With Insulin, run by Centre hospitalier de l'Université de Montréal (CHUM).

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 7 inclusion and 14 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: withdrawn, as of the sponsor's last update on 5 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. 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 was withdrawn before enrolling participants, so there are no results.

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?

The primary outcome of this study will be weight loss in the participants. (time frame: 24 weeks). 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 NCT04957173, 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 Sep 2023.

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