Pharmacist-led Therapeutic Nutritional Intervention in Type 2 Diabetes

Diet Modification Clinical Trial

Official title:

Impact of a Pharmacist-led Therapeutic Nutritional Intervention on Medications and Glucose Control in Type 2 Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03181165
• Other study ID #: H16-01539
• Status: Completed
• Phase: N/A
• Start date: July 5, 2017
• Est. completion date: July 15, 2020

Study information

• Verified date: September 2020
• Source: University of British Columbia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 188
• Est. completion date: July 15, 2020
• Est. primary completion date: November 15, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Diet Modification

Intervention

Behavioral:
• Low-carbohydrate Therapeutic Nutrition
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.

Locations

Country	Name	City	State
Canada	University of British Columbia	Kelowna	British Columbia

Sponsors (3)

Lead Sponsor	Collaborator
University of British Columbia	Mitacs, Pharmasave

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Habitual physical activity	Godin leisure-time exercise questionnaire	12 weeks
Other	Energy intake	3-day diet record	Baseline, 6 weeks, and 12 weeks
Other	Macronutrient intake	3-day diet record	Baseline, 6 weeks, and 12 weeks
Other	Intervention Satisfaction	Satisfaction with intervention delivery questionnaire	12 weeks
Primary	Proportion of participants not on glucose-lowering medications	Number of individuals taking no medications divided by the total number of participants.	12 weeks
Secondary	Hemoglobin A1C	Blood test to measure glucose control	12 weeks
Secondary	Reduction in glucose-lowering medications	Reduction in total dose of glucose-lowering medications	12 weeks
Secondary	Body mass index	Body mass in kilograms divided by height in meters squared.	12 weeks
Secondary	Waist circumference	Waist circumference in centimeters	12 weeks
Secondary	Body fat percentage	Body fat percentage measured by bioelectrical impedance analysis	12 weeks
Secondary	Body mass	Body mass in kg	12 weeks
Secondary	Health related quality of life	Short-form (SF)-20 questionnaire	12 weeks
Secondary	Reduction in non-glucose lowering medications	Dose of medications other than glucose-lowering	12 weeks
Secondary	Blood lipid profile	triglycerides, HDL and LDL cholesterol	12 weeks
Secondary	Fasting insulin	Fasting insulin	12 weeks
Secondary	Fasting C-peptide	fasting C-peptide	12 weeks
Secondary	C-reactive protein	Fasting high-sensitivity C-reactive protein	12 weeks
Secondary	Liver enzymes	liver alanine amino transferase, aspartate aminotransferase, gamma-gluatmyl transpeptidase	12 weeks
Secondary	Fasting plasma glucose	Fasting plasma glucose	12 weeks
Secondary	Systolic Blood Pressure	Systolic Blood Pressure measured by automatic cuff	12 weeks
Secondary	Diastolic Blood Pressure	Diastolic Blood Pressure measured by automatic cuff	12 weeks