DiEt ChoIce to Promote Type 2 Diabetes REmission

NCT05710900 | Recruiting

• 1 other identifier: H22-03055
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Type 2 diabetes is typically viewed as a chronic, progressive, and lifelong condition. Patients and their healthcare providers "manage" type 2 diabetes through lifestyle modifications and various types of medications designed to lower blood sugar. Exciting new research indicates that "remission" of type 2 diabetes - defined as returning blood sugar into the normal range without having to use medications - through therapeutic nutrition may be possible for many people living with the condition. We will examine the preference, adherence and clinical results of a low-calorie diet or low-carbohydrate diet in type 2 diabetes remission rates.

Conditions

Type 2 Diabetes

Keywords

low-carbohydrate diets; low-calorie diets; type 2 diabetes remission

Outcome Measures

Primary Outcomes (3)

• Dual criteria for adherence to dietary interventions

  defined as the proportion of participants attending ≥75% of visits with the pharmacist and/or registered dietitian (RD) and achieving at least 5% weight loss.

  52 weeks

• Intervention preference

  the proportion of participants choosing each intervention

  52 weeks

• Type 2 diabetes remission

  the proportion of participants achieving diabetes remission defined as Hemoglobin A1c (HbA1c) \<6.5% and no glucose-lowering medications for at least 3 months, per international and new Canadian Clinical Practice Guidelines

  52 weeks

Secondary Outcomes (33)

• Body mass

  weeks 0,12 ,20, 39, 52

• Body mass index

  weeks 0,12 ,20, 39, 52

• Waist circumference

  weeks 0,12 ,20, 39, 52

• Blood pressure

  weeks 0,12 ,20, 39, 52

• Hemoglobin A1c

  weeks 0,12 ,20, 39, 52

Study Arms (2)

Low-calorie diet group

EXPERIMENTAL

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.

Other: Dietary intervention

Low-carbohydrate diet group

EXPERIMENTAL

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.

Other: Dietary intervention

Interventions

Dietary intervention OTHER

Each dietary remission strategy involves three phases focused on weight loss and medication deprescribing (Phase 1: Weeks 0-12), transition to an individualized sustainable dietary pattern (Phase 2: Weeks 13-20), and weight loss/remission maintenance (Phase 3: Weeks 21-52).

Low-calorie diet group; Low-carbohydrate diet group

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 20-80 years old
• Diagnosed with T2D by a physician,
• HbA1c ≥ 6.0%,
• Body Mass Index ≥27 kg/m2 and
• No contraindications or dietary restrictions to following a low-carbohydrate/low-calorie diet.

You may not qualify if:

• History of heart disease, heart attack, heart failure, stroke or coronary artery disease within the previous 2 years,
• any current unstable cardiovascular disorder,
• history of liver disease,
• history of kidney disease with eGFR \<30 mls/min/1.73 m2,
• history of neurological disease,
• previous bariatric surgery,
• weight loss (≥5%) within the last six months
• currently pregnant or lactating, or planning on becoming pregnant within the next 12 months,
• history of cancer within the previous 5 years,
• dietary restrictions or allergies that would inhibit adherence to the intervention diet,
• history of eating disorders,
• moderate or severe depression, anxiety or mental health condition that impacts daily life,
• currently following a low-carbohydrate or low-calorie diet, and
• unable to access the Internet (for communication with research team and RD).

Sponsors & Collaborators

• University of British Columbia: lead

Study Sites (1)

University of British Columbia Okanagan

Kelowna, British Columbia, V1V 3G1, Canada

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Diet Therapy

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Nutrition Therapy; Therapeutics

Central Study Contacts

Barbara Oliveira, PhD

CONTACT

(250) 859-9900; barbara.oliveira@ubc.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Pilot implementation study

Study Record Dates

• First Submitted: January 16, 2023
• First Posted: February 2, 2023
• Study Start: July 15, 2023
• Primary Completion: June 15, 2025
• Study Completion (Estimated): November 1, 2026
• Last Updated: March 7, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)