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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LoBAG Diet | Experimental | Assignment to consume the LoBAG diet (30% carbohydrate, 30% protein, 40% fat; carbohydrates that are low in starch emphasized) for 12 weeks. |
|
| Control Diet | Active Comparator | Assignment to consume the control diet (50% carbohydrate, 15% protein, 35% fat) for 12 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Diet Therapy | Other | The intervention for both study groups will be a change in diet. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Hemoglobin A1c From Baseline to Week 12 | Marker of blood sugar control | Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Weight From Baseline to Week 12 | Weight in pounds | Week 12 |
| Change in Fasting Plasma Glucose From Baseline to Week 12 | Blood draw |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anne Bantle, MD | University of Minnesota | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Minnesota | Minneapolis | Minnesota | 55455 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | Control Diet |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Hemoglobin A1c From Baseline to Week 12 | Marker of blood sugar control | Posted | Mean | Standard Deviation | percentage | Week 12 |
|
12 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | General disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Anne Bantle | University of Minnesota | 612-625-8673 | endofixer@umn.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 29, 2021 | Feb 14, 2024 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jul 6, 2021 | Feb 14, 2024 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D004035 | Diet Therapy |
| ID | Term |
|---|---|
| D044623 | Nutrition Therapy |
| D013812 | Therapeutics |
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| Week 12 |
| Change in Fasting Serum Insulin From Baseline to Week 12 | Blood draw | Week 12 |
| 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 | Baseline |
| 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 | Week 12 |
| Change in Serum Fructosamine From Baseline to Week 12 | A marker of blood sugar control, similar to hemoglobin A1c | Week 12 |
| Change in Fasting Serum Lipids From Baseline to Week 12 | Blood draw | Week 12 |
| Diabetes Treatment Satisfaction Questionnaire Score | Questionnaire to determine satisfaction with current diabetes treatment, scored 0 (very dissatisfied) to 36 (very satisfied) | Week 12 |
| 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. | Baseline |
| 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. | Week 6 |
| 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. | Week 12 |
| Urine Nitrogen to Creatinine Ratio | Urine sample | Baseline |
| Urine Nitrogen to Creatinine Ratio | Urine sample | Week 3 |
| Urine Nitrogen to Creatinine Ratio | Urine sample | Week 6 |
| Urine Nitrogen to Creatinine Ratio | Urine sample | Week 9 |
| Urine Nitrogen to Creatinine Ratio | Urine sample | Week 12 |
| Three-day Food Diary | Meal record for 3 days | Baseline |
| Three-day Food Diary | Meal record for 3 days | Week 6 |
| Three-day Food Diary | Meal record for 3 days | Week 12 |
| 24-hour Diet Recall | Interview to review meals consumed in previous 24 hours | Week 9 |
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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Change in Weight From Baseline to Week 12 | Weight in pounds | Not Posted | Week 12 | Participants |
| Secondary | Change in Fasting Plasma Glucose From Baseline to Week 12 | Blood draw | Not Posted | Week 12 | Participants |
| Secondary | Change in Fasting Serum Insulin From Baseline to Week 12 | Blood draw | Not Posted | Week 12 | Participants |
| 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 | Not Posted | Baseline | Participants |
| 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 | Not Posted | Week 12 | Participants |
| Secondary | Change in Serum Fructosamine From Baseline to Week 12 | A marker of blood sugar control, similar to hemoglobin A1c | Not Posted | Week 12 | Participants |
| Secondary | Change in Fasting Serum Lipids From Baseline to Week 12 | Blood draw | Not Posted | Week 12 | Participants |
| Secondary | Diabetes Treatment Satisfaction Questionnaire Score | Questionnaire to determine satisfaction with current diabetes treatment, scored 0 (very dissatisfied) to 36 (very satisfied) | Not Posted | Week 12 | Participants |
| 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. | Not Posted | Baseline | Participants |
| 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. | Not Posted | Week 6 | Participants |
| 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. | Not Posted | Week 12 | Participants |
| Secondary | Urine Nitrogen to Creatinine Ratio | Urine sample | Not Posted | Baseline | Participants |
| Secondary | Urine Nitrogen to Creatinine Ratio | Urine sample | Not Posted | Week 3 | Participants |
| Secondary | Urine Nitrogen to Creatinine Ratio | Urine sample | Not Posted | Week 6 | Participants |
| Secondary | Urine Nitrogen to Creatinine Ratio | Urine sample | Not Posted | Week 9 | Participants |
| Secondary | Urine Nitrogen to Creatinine Ratio | Urine sample | Not Posted | Week 12 | Participants |
| Secondary | Three-day Food Diary | Meal record for 3 days | Not Posted | Baseline | Participants |
| Secondary | Three-day Food Diary | Meal record for 3 days | Not Posted | Week 6 | Participants |
| Secondary | Three-day Food Diary | Meal record for 3 days | Not Posted | Week 12 | Participants |
| Secondary | 24-hour Diet Recall | Interview to review meals consumed in previous 24 hours | Not Posted | Week 9 | Participants |
| 0 |
| 24 |
| 0 |
| 24 |
| 4 |
| 24 |
| EG001 | 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. | 0 | 24 | 0 | 24 | 3 | 24 |
| tingling/neuropathy symptoms | Nervous system disorders | Non-systematic Assessment |
|
| constipation | Gastrointestinal disorders | Non-systematic Assessment |
|
| ear infection | Ear and labyrinth disorders | Non-systematic Assessment |
|
| arm pain | General disorders | Non-systematic Assessment | not related to CGM sensor |
|
| kidney stone | Renal and urinary disorders | Non-systematic Assessment |
|
| back injury | General disorders | Non-systematic Assessment |
|
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| D004700 | Endocrine System Diseases |