Clinical trial NCT03181165: Pharmacist-led Therapeutic Nutritional Intervention in Type 2 Diabetes
Official title: Impact of a Pharmacist-led Therapeutic Nutritional Intervention on Medications and Glucose Control in Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diet Modification
Keywords: Low-carbohydrate
Low calorie
Energy restricted
Lead sponsor: University of British Columbia
Sponsor class: OTHER
Collaborators: name: Mitacs
name: Pharmasave
First posted: 2017-06-08
Enrollment: 188
Sex: ALL
Minimum age (years): 30
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Pragmatic effectiveness trial of diet intervention led by community pharmacists versus treatment-as-usual waitlist control.
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Proportion of participants not on glucose-lowering medications
timeFrame: 12 weeks
Secondary outcomes:
measure: Hemoglobin A1C
timeFrame: 12 weeks
measure: Reduction in glucose-lowering medications
timeFrame: 12 weeks
measure: Body mass index
timeFrame: 12 weeks
measure: Waist circumference
timeFrame: 12 weeks
measure: Body fat percentage
timeFrame: 12 weeks
measure: Body mass
timeFrame: 12 weeks
measure: Health related quality of life
timeFrame: 12 weeks
measure: Reduction in non-glucose lowering medications
timeFrame: 12 weeks
measure: Blood lipid profile
timeFrame: 12 weeks
measure: Fasting insulin
timeFrame: 12 weeks
measure: Fasting C-peptide
timeFrame: 12 weeks
measure: C-reactive protein
timeFrame: 12 weeks
measure: Liver enzymes
timeFrame: 12 weeks
measure: Fasting plasma glucose
timeFrame: 12 weeks
measure: Systolic Blood Pressure
timeFrame: 12 weeks
measure: Diastolic Blood Pressure
timeFrame: 12 weeks
Other outcomes:
measure: Habitual physical activity
timeFrame: 12 weeks
measure: Energy intake
timeFrame: Baseline, 6 weeks, and 12 weeks
measure: Macronutrient intake
timeFrame: Baseline, 6 weeks, and 12 weeks
measure: Intervention Satisfaction
timeFrame: 12 weeks
Locations:
city: Kelowna
country: Canada
facility: University of British Columbia
state: British Columbia
Study officials:
affiliation: University of British Columbia
name: Jonathan P Little, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.