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NCT05710900 | Recruiting | Type 2 Diabetes

DiEt ChoIce to Promote Type 2 Diabetes rEmission
Sponsor:

University of British Columbia

Information provided by (Responsible Party):

Jonathan Little

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.

Condition or disease

Type 2 Diabetes

Intervention/treatment

Dietary intervention

Phase

Not Applicable

Detailed 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.}}

Study Type : Interventional
Estimated Enrollment : 100 participants
Masking : None (Open Label)
Primary Purpose : Treatment
Official Title : DECIDE: DiEt ChoIce to Promote Type 2 Diabetes rEmission Supported by Community Pharmacists and Registered Dietitians
Actual Study Start Date : July 15, 2023
Estimated Primary Completion Date : June 15, 2025
Estimated Study Completion Date : November 1, 2026
Arm Intervention/treatment

Experimental: Low-calorie diet group

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

Experimental: Low-carbohydrate diet group

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
Ages Eligible for Study: 20 Years to 80 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Criteria
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).
DiEt ChoIce to Promote Type 2 Diabetes rEmission

Location Details

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DiEt ChoIce to Promote Type 2 Diabetes rEmission

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Locations

Recruiting

Canada, British Columbia

University of British Columbia Okanagan

Kelowna, British Columbia, Canada, V1V 3G1