Continuous Glucose Monitoring (CGM) With a Low Carbohydrate Diet to Reduce Weight in Patients With Pre-Diabetes

NCT ID: NCT03695913

Last Updated: 2020-03-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-10-16
• Study Completion Date: 2019-09-26

Brief Summary

This study will recruit pre-diabetic patients to see if continuous glucose monitoring (CGM) with a low carbohydrate diet can reduce the percentage of time the CGM readings are above the normal range. Through this study it will demonstrate the feasibility of using CGM with a low carbohydrate diet to reduce weight and risk of developing diabetes in patients with pre-diabetes.

Patients that appear to be eligible will be recruited from Michigan Medicine in the Family Medicine Clinic at the Livonia Center.

Conditions

Pre-diabetes

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Normal Diet + CGM then low carb + CGM

Phase I (part 1) - regular diet:

Patients will wear a CGM sensor (with no real time feedback) for 11 days; document what they eat on a food log; and rate their postprandial fatigue and cravings.

Phase II (part 2) - low carb diet:

Patients will wear a CGM sensor (with real time feedback) for 11 days; document what they eat on a food log; and rate their postprandial fatigue and cravings; document their blood sugar before and two hours after eating (as well as before breakfast and before going to bed).

Group Type: EXPERIMENTAL

Normal Diet

Intervention Type: OTHER

Phase I (regular diet):

all participants will eat their normal diet and will log their food.

Low carb diet

Intervention Type: OTHER

Phase II (low carb diet):

participants will be asked to eat a low carb diet and log their food

CGM with no real time feedback

Intervention Type: DEVICE

Phase I will collect CGM without real time feedback

CGM with real time feedback)

Intervention Type: DEVICE

Phase II participants will be asked to scan their sensor at least every eight hours and document their blood sugar before and two hours after eating as well as before breakfast and before going to bed.

Education material

Intervention Type: BEHAVIORAL

Phase I: participants will be given the book Always Hungry and be asked to read chapters 1-5 after a health check phone call approximately 5 days after the sensor is placed.

Phase II: participants will be taught about carbohydrates and the benefits and side effects. Additionally, they will be given multiple resources to assist them regarding carbohydrates as well as a book entitled "The Calorie King, Calories, Fat, and Carbohydrates." Groceries will also be delivered for 2 recipes that the participants choose from to make.

Interventions

Normal Diet

Phase I (regular diet):

all participants will eat their normal diet and will log their food.

Intervention Type: OTHER

Low carb diet

Phase II (low carb diet):

participants will be asked to eat a low carb diet and log their food

Intervention Type: OTHER

CGM with no real time feedback

Phase I will collect CGM without real time feedback

Intervention Type: DEVICE

CGM with real time feedback)

Phase II participants will be asked to scan their sensor at least every eight hours and document their blood sugar before and two hours after eating as well as before breakfast and before going to bed.

Intervention Type: DEVICE

Education material

Phase I: participants will be given the book Always Hungry and be asked to read chapters 1-5 after a health check phone call approximately 5 days after the sensor is placed.

Phase II: participants will be taught about carbohydrates and the benefits and side effects. Additionally, they will be given multiple resources to assist them regarding carbohydrates as well as a book entitled "The Calorie King, Calories, Fat, and Carbohydrates." Groceries will also be delivered for 2 recipes that the participants choose from to make.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• A1C Glucose Measurement between 5.7 to 6.4 (for most recent A1C test, not older than 1 year)
• No diabetes medication including Metformin
• BMI (body mass index) >30
• Must speak, read, and write in English
• No current pregnancy or breastfeeding
• Must not classify as either Vegan or Vegetarian
• Must be a patient at the Livonia Health Center

Exclusion Criteria

• previous bariatric surgery

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Michigan

OTHER

Sponsor Role: lead

Responsible Party

Caroline Richardson

Dr Max and Buena Lichter Research Professor of Family Medicine, Assistant Chair, Department of Family Medicine and Professor of Family Medicine, Medical School

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Caroline Richardson, MD

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Locations

The University of Michigan

Livonia, Michigan, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Other Identifiers

HUM00145667

Identifier Type: -

Identifier Source: org_study_id