The LoBAG Diet and Type 2 Diabetes Mellitus
| Status: | Recruiting |
|---|---|
| Conditions: | Diabetes, Diabetes |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | 18 - 100 |
| Updated: | 5/3/2018 |
| Start Date: | March 28, 2017 |
| End Date: | December 2018 |
| Contact: | Anne Bantle, MD |
| Email: | d-study@umn.edu |
| Phone: | 612-625-8673 |
A Low Biologically Available Glucose and High Protein Diet for Treatment of Type 2 Diabetes Mellitus
This study will investigate the use of a low biologically available and high protein diet
(LoBAG) for treatment of type 2 diabetes mellitus. Subjects with type 2 diabetes will be
recruited and asked to adhere to this diet or a control diet for 12 weeks. Food preparation
will be done by subjects at home, following instruction from the study team including a
dietitian. The study will test the hypothesis that the LoBAG diet will lead to a greater
reduction in hemoglobin A1c (HgbA1c) than a control diet over 12 weeks of intervention.
(LoBAG) for treatment of type 2 diabetes mellitus. Subjects with type 2 diabetes will be
recruited and asked to adhere to this diet or a control diet for 12 weeks. Food preparation
will be done by subjects at home, following instruction from the study team including a
dietitian. The study will test the hypothesis that the LoBAG diet will lead to a greater
reduction in hemoglobin A1c (HgbA1c) than a control diet over 12 weeks of intervention.
Diet is a cornerstone of type 2 diabetes mellitus treatment. Current standard of care diet
recommendations focus on caloric restriction and weight loss, goals which can be difficult to
achieve. A moderate carbohydrate, high protein diet has been designed specifically for people
with type 2 diabetes, and has shown promising results in preliminary studies. This diet,
called the Low Biologically Available Glucose (LoBAG) diet, does not require caloric
restriction or weight loss to produce beneficial effects. The purpose of this project is to
expand upon the preliminary studies and to offer the LoBAG diet to a free-living population
of people with type 2 diabetes (people who come to outpatient study visits for diet
instruction, and then prepare and consume food in their own homes).
People with type 2 diabetes will be enrolled in a randomized, parallel group trial of the
LoBAG diet or a control diet over a 12 week intervention period. Diet assignment will be
random (like the flip of a coin). The main intervention will be instruction in either the
LoBAG diet or the control diet. Measures of diabetes control will be collected before,
during, and after the diet intervention. Stool samples will be used to collect preliminary
data on the gut microbiome during the diet intervention. The diets will be isocaloric and
subjects will not lose weight during the study. There will be 6 study visits over a 12-13
week period.
recommendations focus on caloric restriction and weight loss, goals which can be difficult to
achieve. A moderate carbohydrate, high protein diet has been designed specifically for people
with type 2 diabetes, and has shown promising results in preliminary studies. This diet,
called the Low Biologically Available Glucose (LoBAG) diet, does not require caloric
restriction or weight loss to produce beneficial effects. The purpose of this project is to
expand upon the preliminary studies and to offer the LoBAG diet to a free-living population
of people with type 2 diabetes (people who come to outpatient study visits for diet
instruction, and then prepare and consume food in their own homes).
People with type 2 diabetes will be enrolled in a randomized, parallel group trial of the
LoBAG diet or a control diet over a 12 week intervention period. Diet assignment will be
random (like the flip of a coin). The main intervention will be instruction in either the
LoBAG diet or the control diet. Measures of diabetes control will be collected before,
during, and after the diet intervention. Stool samples will be used to collect preliminary
data on the gut microbiome during the diet intervention. The diets will be isocaloric and
subjects will not lose weight during the study. There will be 6 study visits over a 12-13
week period.
Inclusion Criteria:
- 18 years of age or older
- Diagnosis of type 2 diabetes mellitus
- Hemoglobin A1c of 7.5-9.5%
- Taking no medications for diabetes or taking metformin
Exclusion Criteria:
- Type 1 diabetes mellitus
- Treatment with insulin
- BMI <27 kg/m2
- Change in weight of more than 5 pounds in the prior 3 months
- Serum creatinine >1.5 mg/dL
- Urine albumin >300 mg/g creatinine
- Pregnancy or immediate plans to become pregnant
- Breast feeding
- Dietary restriction(s) that would preclude consumption of the LoBAG diet
- Inability or unwillingness to prepare meals
- Presence of any disease which would make adherence to the study protocol difficult
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