Type 2 Diabetes Mellitus
Conditions
Keywords
diet, carbohydrate, protein, glucose, type 2 diabetes mellitus
Brief summary
The proposed study is a randomized controlled, pilot effectiveness trial comparing the LoBAG diet to a control diet in 38 participants with DM2 over 12 weeks. Participants will have DM2 that is not under ideal glycemic control (HgbA1c 7.0-9.5%) and must be taking no glycemic medications or metformin. Participants will be free-living (given diet instruction and dietitian support, but asked to prepare meals in their own homes). The primary endpoint will be HgbA1c, measured at baseline and at the end of the 12-week diet intervention. Additional outcome measures will include: weight, fasting plasma glucose, fasting serum insulin, postprandial plasma glucose and serum insulin following a test meal consistent with the assigned diet, serum fructosamine, fasting serum lipids, stool samples for gut microbiome analysis, and surveys to assess quality of life, including the Diabetes Treatment Satisfaction Questionnaire. Compliance outcomes will include: urine nitrogen to creatinine ratio, survey data, three-day food diaries, and unannounced 24-hour diet recalls.
Detailed description
Thirty-eight adult men and women with DM2 will be recruited from the University of Minnesota and surrounding communities, and will be randomized to treatment with the LoBAG diet or a control diet. Following a consent and screening visit, there will be 5 additional study visits over a 12-week diet intervention period. Instruction in the assigned diet will be provided by a research dietitian at the beginning of the 12-week period, and reinforced at subsequent visits throughout the study. Participants will be asked to purchase food, prepare food, and consume the assigned diet in their own homes. They will be asked to keep activity level constant and to continue medications for diabetes (metformin or no medication) without change during the intervention. The primary outcome, HgbA1c, and secondary outcome measures will be assessed at baseline and following diet intervention. Study visits will occur at baseline (visits 1 and 2), week 1 (visit 3), week 6 (visit 4), week 9 (visit 5) and week 12 (final study visit). In addition to scheduled study visits the research team will contact participants every other week by telephone to address any issues that arise, with the purpose of increasing compliance and retention. Participants will be contacted once in weeks 9-12 for a 24-hour diet recall collected by the Nutrition Coordinating Center at the University of Minnesota. Study procedures will conclude after the 12-week diet intervention period and collection of all outcome measures.
Interventions
OTHERDiet Therapy
The intervention for both study groups will be a change in diet.
Sponsors
University of Minnesota
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 18 years of age or older * Diagnosis of type 2 diabetes mellitus * Hemoglobin A1c of 7.0-9.5% * Taking no medications for diabetes or taking metformin
Exclusion criteria
* Type 1 diabetes mellitus * Treatment with insulin * BMI \< 27 kg/m\^2 * Change in weight of more than 5 pounds in the prior 3 months * Estimated glomerular filtration rate (GFR) \< 60 ml/minute/1.73 m\^2 * Urine albumin \> 300 mg/g creatinine * Anemia * Pregnancy or immediate plans to become pregnant * Current breast feeding * Use of antibiotics in the 3 month period prior to study enrollment * Dietary restriction(s) that would preclude consumption of the study diets * Inability or unwillingness to prepare meals * Presence of any disease which would make adherence to the study protocol difficult
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Hemoglobin A1c From Baseline to Week 12 | Week 12 | Marker of blood sugar control |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Fasting Plasma Glucose From Baseline to Week 12 | Week 12 | Blood draw |
| Change in Fasting Serum Insulin From Baseline to Week 12 | Week 12 | Blood draw |
| Postprandial Plasma Glucose and Serum Insulin Following a Test Meal | Baseline | A meal will be provided, and blood drawn at regular intervals for 4 hours following the meal |
| Change in Serum Fructosamine From Baseline to Week 12 | Week 12 | A marker of blood sugar control, similar to hemoglobin A1c |
| Change in Fasting Serum Lipids From Baseline to Week 12 | Week 12 | Blood draw |
| Change in Weight From Baseline to Week 12 | Week 12 | Weight in pounds |
| Gut Microbiome Composition | Baseline | The human gut microbiome refers to the bacteria, fungi, and viruses that inhabit the human intestine. Participants will be asked to collect a small sample of stool on a swab. Collection will be done at home. |
| Urine Nitrogen to Creatinine Ratio | Baseline | Urine sample |
| Three-day Food Diary | Baseline | Meal record for 3 days |
| 24-hour Diet Recall | Week 9 | Interview to review meals consumed in previous 24 hours |
| Diabetes Treatment Satisfaction Questionnaire Score | Week 12 | Questionnaire to determine satisfaction with current diabetes treatment, scored 0 (very dissatisfied) to 36 (very satisfied) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| LoBAG Diet Assignment to consume the LoBAG diet (30% carbohydrate, 30% protein, 40% fat; carbohydrates that are low in starch emphasized) for 12 weeks.
Diet Therapy: The intervention for both study groups will be a change in diet. | 24 |
| Control Diet Assignment to consume the control diet (50% carbohydrate, 15% protein, 35% fat) for 12 weeks.
Diet Therapy: The intervention for both study groups will be a change in diet. | 24 |
| Total | 48 |
Baseline characteristics
| Characteristic | Control Diet | Total | LoBAG Diet |
|---|---|---|---|
| Age, Continuous | 55.8 years STANDARD_DEVIATION 11.5 | 57.4 years STANDARD_DEVIATION 10.3 | 59.0 years STANDARD_DEVIATION 9.1 |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants | 7 Participants | 3 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) White | 16 Participants | 37 Participants | 21 Participants |
| Sex: Female, Male Female | 18 Participants | 30 Participants | 12 Participants |
| Sex: Female, Male Male | 6 Participants | 18 Participants | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 24 | 0 / 24 |
| other Total, other adverse events | 4 / 24 | 3 / 24 |
| serious Total, serious adverse events | 0 / 24 | 0 / 24 |
Outcome results
Primary
Change in Hemoglobin A1c From Baseline to Week 12
Marker of blood sugar control
Time frame: Week 12
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| LoBAG Diet | Change in Hemoglobin A1c From Baseline to Week 12 | 6.6 percentage | Standard Deviation 0.6 |
| Control Diet | Change in Hemoglobin A1c From Baseline to Week 12 | 7.2 percentage | Standard Deviation 0.8 |
Secondary
24-hour Diet Recall
Interview to review meals consumed in previous 24 hours
Time frame: Week 9
Secondary
Change in Fasting Plasma Glucose From Baseline to Week 12
Blood draw
Time frame: Week 12
Secondary
Change in Fasting Serum Insulin From Baseline to Week 12
Blood draw
Time frame: Week 12
Secondary
Change in Fasting Serum Lipids From Baseline to Week 12
Blood draw
Time frame: Week 12
Secondary
Change in Serum Fructosamine From Baseline to Week 12
A marker of blood sugar control, similar to hemoglobin A1c
Time frame: Week 12
Secondary
Change in Weight From Baseline to Week 12
Weight in pounds
Time frame: Week 12
Secondary
Diabetes Treatment Satisfaction Questionnaire Score
Questionnaire to determine satisfaction with current diabetes treatment, scored 0 (very dissatisfied) to 36 (very satisfied)
Time frame: Week 12
Secondary
Gut Microbiome Composition
The human gut microbiome refers to the bacteria, fungi, and viruses that inhabit the human intestine. Participants will be asked to collect a small sample of stool on a swab. Collection will be done at home.
Time frame: Week 12
Secondary
Gut Microbiome Composition
The human gut microbiome refers to the bacteria, fungi, and viruses that inhabit the human intestine. Participants will be asked to collect a small sample of stool on a swab. Collection will be done at home.
Time frame: Week 6
Secondary
Gut Microbiome Composition
The human gut microbiome refers to the bacteria, fungi, and viruses that inhabit the human intestine. Participants will be asked to collect a small sample of stool on a swab. Collection will be done at home.
Time frame: Baseline
Secondary
Postprandial Plasma Glucose and Serum Insulin Following a Test Meal
A meal will be provided, and blood drawn at regular intervals for 4 hours following the meal
Time frame: Week 12
Secondary
Postprandial Plasma Glucose and Serum Insulin Following a Test Meal
A meal will be provided, and blood drawn at regular intervals for 4 hours following the meal
Time frame: Baseline
Secondary
Three-day Food Diary
Meal record for 3 days
Time frame: Week 12
Secondary
Three-day Food Diary
Meal record for 3 days
Time frame: Baseline
Secondary
Three-day Food Diary
Meal record for 3 days
Time frame: Week 6
Secondary
Urine Nitrogen to Creatinine Ratio
Urine sample
Time frame: Week 9
Secondary
Urine Nitrogen to Creatinine Ratio
Urine sample
Time frame: Week 6
Secondary
Urine Nitrogen to Creatinine Ratio
Urine sample
Time frame: Week 3
Secondary
Urine Nitrogen to Creatinine Ratio
Urine sample
Time frame: Baseline
Secondary
Urine Nitrogen to Creatinine Ratio
Urine sample
Time frame: Week 12