Pharmacist-led Therapeutic Nutritional Intervention in Type 2 Diabetes

Not Applicable

Completed

• Conditions: Diet Modification
• Interventions: Behavioral: Low-carbohydrate Therapeutic Nutrition

• Registration Number: NCT03181165
• Lead Sponsor: University of British Columbia

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-06-06
• Study First Submitted QC: 2017-06-06
• Study First Posted: 2017-06-08
• Study Start: 2017-07-05
• Primary Completion: 2019-11-15
• Study Completion: 2020-07-15
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-09
• Last Update Posted: 2020-09-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 188

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Low-carbohydrate Therapeutic Nutrition	Low-carbohydrate Therapeutic Nutrition	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.

Primary Outcome Measures

Name	Time	Method
Proportion of participants not on glucose-lowering medications	12 weeks	Number of individuals taking no medications divided by the total number of participants.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University of British Columbia; 🇨🇦 Kelowna, British Columbia, Canada