DiEt ChoIce to Promote Type 2 Diabetes REmission (DECIDE)

University of British Columbia

Status: Enrolling

Conditions: Type 2 Diabetes

Treatments: Other: Dietary intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT05710900

H22-03055

Details and patient eligibility

About

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.

Full description

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). We will determine if there is a preference for one diet over the other, measure satisfaction with each approach, and determine clinical outcomes (T2D remission, medication use, blood biomarkers) at one year. Qualitative interviews and feedback surveys with the participants, pharmacists, and RD will provide information on barriers and facilitators to each T2D remission strategy.

Enrollment: 100 estimated patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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).

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

100 participants in 2 patient groups

Low-calorie diet group

Experimental group

Description:

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.

Treatment:

Other: Dietary intervention

Low-carbohydrate diet group

Experimental group

Description:

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.

Treatment:

Other: Dietary intervention