Pharmacist-led Therapeutic Nutritional Intervention in Type 2 Diabetes

University of British Columbia

Status: Completed

Conditions: Diet Modification

Treatments: Behavioral: Low-carbohydrate Therapeutic Nutrition

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03181165

H16-01539

Details and patient eligibility

About

Type 2 diabetes represents a significant burden to both the individual and our healthcare system. Individuals with type 2 diabetes are typically prescribed one or more glucose-lowering medications, many of which have undesirable side effects (e.g., nausea, risk of cardiovascular complications, weight gain) and cost our healthcare system a lot of money. An alternative strategy to lower blood glucose is to consume a low-carbohydrate diet. However, adjusting medications after choosing to follow a low-carbohydrate diet can be difficult. Delivering a low-carbohydrate diet through pharmacists could circumvent this difficulty in medications adjustment because pharmacists are trained to adjust medications. In this study the investigators will determine whether type 2 diabetes patients can reduce medications and improve blood glucose by following a low-carbohydrate, low-calorie diet under the direction of a pharmacist.

Enrollment: 188 patients

Sex: All

Ages: 30 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Between the ages of 30 and 75, have type 2 diabetes mellitus diagnosed by a physician, are taking one or more glucose-lowering medications, have a BMI ≥30, have no contraindications to following low-carbohydrate, energy-restricted, high-protein diet, and can read and speak English.

Exclusion criteria

Exlcusion criteria are:

1. Recent (within the last 2 years) diagnosis of coronary heart disease, stroke, or a heart attack.
2. Unstable cardiovascular disorder.
3. History of liver disease.
4. History of kidney disease or impaired renal function.
5. Previously undergone bariatric surgery.
6. Multiple sclerosis or other diagnosed neurological disease.
7. Currently pregnant or lactating, or planning on becoming pregnant in the next 12 months.
8. Any form of cancer within the last 5 years.
9. Body mass index (BMI) of <30.
10. Dietary restrictions that do not allow you to follow a low-carbohydrate, energy-restricted, high-protein diet (e.g., vegan, food allergies).
11. Any sensitivities to the ingredients in the pre-packaged foods

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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188 participants in 2 patient groups

Low-carbohydrate Therapeutic Nutrition

Experimental group

Description:

A 12-week low-carbohydrate, energy-restricted diet will be administered using a combination of pre-packaged foods and whole foods from pre-specified lists.

Treatment:

Behavioral: Low-carbohydrate Therapeutic Nutrition

Treatment-as-usual waitlist control

No Intervention group

Description:

Participants will receive standard lifestyle advice to follow a low-fat, low-sugar, high fibre diet and aim to accumulate 150 minutes of moderate activity per week.