Pharmacist-led Therapeutic Nutritional Intervention in Type 2 Diabetes

NCT03181165 | Completed DMC

• 1 other identifier: H16-01539
• Study Type: interventional
• Target: 188
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Diet Modification

Keywords

Low-carbohydrate; Low calorie; Energy restricted

Outcome Measures

Primary Outcomes (1)

• Proportion of participants not on glucose-lowering medications

  Number of individuals taking no medications divided by the total number of participants.

  12 weeks

Secondary Outcomes (16)

• Hemoglobin A1C

  12 weeks

• Reduction in glucose-lowering medications

  12 weeks

• Body mass index

  12 weeks

• Waist circumference

  12 weeks

• Body fat percentage

  12 weeks

Other Outcomes (4)

• Habitual physical activity

  12 weeks

• Energy intake

  Baseline, 6 weeks, and 12 weeks

• Macronutrient intake

  Baseline, 6 weeks, and 12 weeks

Study Arms (2)

Low-carbohydrate Therapeutic Nutrition

EXPERIMENTAL

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.

Behavioral: Low-carbohydrate Therapeutic Nutrition

Treatment-as-usual waitlist control

NO INTERVENTION

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.

Interventions

Low-carbohydrate Therapeutic Nutrition BEHAVIORAL

The pharmacist or pharmacy lifestyle coach will work with the participant to develop a diet plan that is low in carbohydrate and energy-restricted based on personal preferences and characteristics. A combination of pre-packaged low-carbohydrate foods and whole foods from pre-specified lists will be used.

Low-carbohydrate Therapeutic Nutrition

Eligibility Criteria

• Age: 30 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University of British Columbia: lead
• Mitacs: collaborator
• Pharmasave: collaborator

Study Sites (1)

University of British Columbia

Kelowna, British Columbia, V1V1V7, Canada

Location

Related Publications (3)

• Durrer C, Islam H, Cen HH, Garzon MDM, Lyu X, McKelvey S, Singer J, Batterham AM, Long JZ, Johnson JD, Little JP. A secondary analysis of indices of hepatic and beta cell function following 12 weeks of carbohydrate and energy restriction vs. free-living control in adults with type 2 diabetes. Nutr Metab (Lond). 2024 May 27;21(1):29. doi: 10.1186/s12986-024-00807-x.

  PMID: 38797835 DERIVED

• Durrer C, McKelvey S, Singer J, Batterham AM, Johnson JD, Gudmundson K, Wortman J, Little JP. A randomized controlled trial of pharmacist-led therapeutic carbohydrate and energy restriction in type 2 diabetes. Nat Commun. 2021 Sep 10;12(1):5367. doi: 10.1038/s41467-021-25667-4.

  PMID: 34508090 DERIVED

• Durrer C, McKelvey S, Singer J, Batterham AM, Johnson JD, Wortman J, Little JP. Pharmacist-led therapeutic carbohydrate restriction as a treatment strategy for type 2 diabetes: the Pharm-TCR randomized controlled trial protocol. Trials. 2019 Dec 27;20(1):781. doi: 10.1186/s13063-019-3873-7.

  PMID: 31881991 DERIVED

Study Officials

• Jonathan P Little, PhD

  University of British Columbia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Participants will know group assignments
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Pragmatic effectiveness trial of diet intervention led by community pharmacists versus treatment-as-usual waitlist control.

Study Record Dates

• First Submitted: June 6, 2017
• First Posted: June 8, 2017
• Study Start: July 5, 2017
• Primary Completion: November 15, 2019
• Study Completion: July 15, 2020
• Last Updated: September 11, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)