Pharmacist-led Therapeutic Nutritional Intervention in Type 2 Diabetes

Study Overview
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Brief Summary
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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.

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

Conditions
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Diet Modification

Intervention / Treatment
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* Behavioral: Low-carbohydrate Therapeutic Nutrition


Participation Criteria
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Eligibility Criteria
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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: 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

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Pragmatic effectiveness trial of diet intervention led by community pharmacists versus treatment-as-usual waitlist control.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Low-carbohydrate Therapeutic Nutrition<br>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<br>* 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.<br>|
| No Intervention: Treatment-as-usual waitlist control<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of participants not on glucose-lowering medications | Number of individuals taking no medications divided by the total number of participants. | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hemoglobin A1C | Blood test to measure glucose control | 12 weeks | 
| Reduction in glucose-lowering medications | Reduction in total dose of glucose-lowering medications | 12 weeks | 
| Body mass index | Body mass in kilograms divided by height in meters squared. | 12 weeks | 
| Waist circumference | Waist circumference in centimeters | 12 weeks | 
| Body fat percentage | Body fat percentage measured by bioelectrical impedance analysis | 12 weeks | 
| Body mass | Body mass in kg | 12 weeks | 
| Health related quality of life | Short-form (SF)-20 questionnaire | 12 weeks | 
| Reduction in non-glucose lowering medications | Dose of medications other than glucose-lowering | 12 weeks | 
| Blood lipid profile | triglycerides, HDL and LDL cholesterol | 12 weeks | 
| Fasting insulin | Fasting insulin | 12 weeks | 
| Fasting C-peptide | fasting C-peptide | 12 weeks | 
| C-reactive protein | Fasting high-sensitivity C-reactive protein | 12 weeks | 
| Liver enzymes | liver alanine amino transferase, aspartate aminotransferase, gamma-gluatmyl transpeptidase | 12 weeks | 
| Fasting plasma glucose | Fasting plasma glucose | 12 weeks | 
| Systolic Blood Pressure | Systolic Blood Pressure measured by automatic cuff | 12 weeks | 
| Diastolic Blood Pressure | Diastolic Blood Pressure measured by automatic cuff | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Low-carbohydrate, Low calorie, Energy restricted