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Dietary Intervention for Type 2 Diabetes (DECIDE Trial)

N/A

Recruiting

Research Sponsored by University of British Columbia

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Aged 20-80 years old

Diagnosed with T2D by a physician

Timeline

Screening 3 weeks

Treatment Varies

Follow Up weeks 1,12 ,20, 39, 52

Awards & highlights

DECIDE Trial Summary

This trial will look at people with type 2 diabetes to see if a low-calorie or low-carb diet can put them into remission, with no need for medication.

Who is the study for?

This trial is for adults aged 20-80 with Type 2 Diabetes, an HbA1c level of at least 6.0%, and a BMI over 27 kg/m2. Participants should be able to follow a low-calorie or low-carbohydrate diet without dietary restrictions and must have internet access. Those who've recently lost weight, had bariatric surgery, severe mental health issues, recent serious illnesses like cancer or heart disease, eating disorders, or are pregnant can't join.Check my eligibility

What is being tested?

The study explores whether Type 2 Diabetes can go into remission through diet alone—without medications. It compares the effectiveness of a low-calorie diet versus a low-carbohydrate diet on lowering blood sugar levels to normal ranges.See study design

What are the potential side effects?

Potential side effects from the dietary interventions may include nutritional deficiencies if not properly managed, changes in energy levels due to altered food intake, digestive changes such as constipation or diarrhea depending on the diet composition.

DECIDE Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 20 and 80 years old.

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I have been diagnosed with Type 2 Diabetes by a doctor.

DECIDE Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ weeks 1,12 ,20, 39, 52

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~weeks 1,12 ,20, 39, 52

This trial's timeline: 3 weeks for screening, Varies for treatment, and weeks 1,12 ,20, 39, 52 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Dual criteria for adherence to dietary interventions

Intervention preference

Type 2 diabetes remission

Secondary outcome measures

2-hour postprandial hyperglycemia

24hr average glucose area under the curve (AUC)

Anti-hypertensive medication

+31 more

DECIDE Trial Design

2Treatment groups

Experimental Treatment

Group I: Low-carbohydrate diet groupExperimental Treatment1 Intervention

The low-carbohydrate diet will involve an individualized whole-food diet (30-130 grams carbohydrate per day) led through virtual visits with a registered dietitian.

Group II: Low-calorie diet groupExperimental Treatment1 Intervention

A low-calorie diet involving will involve a commercial weight loss program (pre-packaged foods from Ideal Protein, select lean protein sources, non-starchy vegetables) and be led by the pharmacist and registered dietitian (RD) involving in-person and virtual appointments.

0 / 2Eligibility criteria met

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Who is running the clinical trial?

University of British ColumbiaLead Sponsor

1,418 Previous Clinical Trials

2,467,018 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this research protocol cater to elderly participants?

"This clinical trial is seeking patients between 20 and 80 years old. For younger participants, there are 194 studies available while 1159 exist for those over 65."

Answered by AI

Is enrollment for this investigation open to participants?

"As indicated on clinicaltrials.gov, this research project is still recruiting patients and was first posted to the site in mid-July of 2023 with edits made in late October of that same year."

Answered by AI

How many people are eligible to enroll in this medical trial?

"Affirmative, a review of clinicaltrials.gov reveals that this research endeavour is actively enrolling subjects. Initially posted on July 15th 2023 and recently modified on October 23rd 2023, the study seeks to recruit 100 individuals from one site."

Answered by AI

What results are researchers aiming to achieve through this clinical trial?

"This clinical trial is planned to last 52 weeks, and the primary purpose of it is to measure patient preference for an intervention. Additionally, sleep activity will be monitored using a GENEActiv accelerometer worn over 14 days at each timepoint; hunger and satiety will be measured through a Visual Analogue Scale questionnaire; while self-esteem scale will take into account 10 items on a questionairre."

Answered by AI

Who would meet the criteria for participation in this experiment?

"In order to join this experiment, the participating candidates must be aged between 20 and 80 years old, have been medically diagnosed with type 2 diabetes (T2D), possess an HbA1c of 6.0% or higher while taking at least one glucose-lowering medication, a Body Mass Index of 27 kg/m2 or above with no contraindications or dietary restrictions that would prevent them from following a low-carbohydrate/low-calorie diet plan. The total number of volunteers being recruited is 100 people.."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

DiEt ChoIce to Promote Type 2 Diabetes rEmission

Jonathan Little 2023. "DiEt ChoIce to Promote Type 2 Diabetes rEmission". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05710900.