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The LoBAG Diet and Type 2 Diabetes Mellitus

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ClinicalTrials.gov Identifier: NCT02717078
Recruitment Status : Recruiting
First Posted : March 23, 2016
Last Update Posted : August 10, 2022
Sponsor:
Information provided by (Responsible Party):
University of Minnesota

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.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Other: Diet Therapy Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Weight Neutral, High Protein, Moderate Carbohydrate Diet for Treatment of Type 2 Diabetes Mellitus
Actual Study Start Date : June 19, 2017
Estimated Primary Completion Date : January 1, 2023
Estimated Study Completion Date : January 1, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: LoBAG Diet
Assignment to consume the LoBAG diet (30% carbohydrate, 30% protein, 40% fat; carbohydrates that are low in starch emphasized) for 12 weeks.
Other: Diet Therapy
The intervention for both study groups will be a change in diet.

Active Comparator: Control Diet
Assignment to consume the control diet (50% carbohydrate, 15% protein, 35% fat) for 12 weeks.
Other: Diet Therapy
The intervention for both study groups will be a change in diet.




Primary Outcome Measures :
  1. Change in hemoglobin A1c from baseline to week 12 [ Time Frame: Week 12 ]
    Marker of blood sugar control


Secondary Outcome Measures :
  1. Change in weight from baseline to week 12 [ Time Frame: Week 12 ]
    Weight in pounds

  2. Change in fasting plasma glucose from baseline to week 12 [ Time Frame: Week 12 ]
    Blood draw

  3. Change in fasting serum insulin from baseline to week 12 [ Time Frame: Week 12 ]
    Blood draw

  4. Postprandial plasma glucose and serum insulin following a test meal [ Time Frame: Baseline ]
    A meal will be provided, and blood drawn at regular intervals for 4 hours following the meal

  5. Postprandial plasma glucose and serum insulin following a test meal [ Time Frame: Week 12 ]
    A meal will be provided, and blood drawn at regular intervals for 4 hours following the meal

  6. Change in serum fructosamine from baseline to week 12 [ Time Frame: Week 12 ]
    A marker of blood sugar control, similar to hemoglobin A1c

  7. Change in fasting serum lipids from baseline to week 12 [ Time Frame: Week 12 ]
    Blood draw

  8. Diabetes Treatment Satisfaction Questionnaire score [ Time Frame: Week 12 ]
    Questionnaire to determine satisfaction with current diabetes treatment, scored 0 (very dissatisfied) to 36 (very satisfied)

  9. Gut microbiome composition [ Time Frame: 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.

  10. Gut microbiome composition [ Time Frame: Week 6 ]
    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.

  11. Gut microbiome composition [ Time Frame: Week 12 ]
    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.

  12. Urine nitrogen to creatinine ratio [ Time Frame: Baseline ]
    Urine sample

  13. Urine nitrogen to creatinine ratio [ Time Frame: Week 3 ]
    Urine sample

  14. Urine nitrogen to creatinine ratio [ Time Frame: Week 6 ]
    Urine sample

  15. Urine nitrogen to creatinine ratio [ Time Frame: Week 9 ]
    Urine sample

  16. Urine nitrogen to creatinine ratio [ Time Frame: Week 12 ]
    Urine sample

  17. Three-day food diary [ Time Frame: Baseline ]
    Meal record for 3 days

  18. Three-day food diary [ Time Frame: Week 6 ]
    Meal record for 3 days

  19. Three-day food diary [ Time Frame: Week 12 ]
    Meal record for 3 days

  20. 24-hour diet recall [ Time Frame: Week 9 ]
    Interview to review meals consumed in previous 24 hours



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02717078


Contacts
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Contact: Anne Bantle, MD 612-625-8673 d-study@umn.edu

Locations
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United States, Minnesota
University of Minnesota Recruiting
Minneapolis, Minnesota, United States, 55455
Contact: Anne Bantle    612-625-8673    d-study@umn.edu   
Sponsors and Collaborators
University of Minnesota
Investigators
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Principal Investigator: Anne Bantle, MD University of Minnesota
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Responsible Party: University of Minnesota
ClinicalTrials.gov Identifier: NCT02717078    
Other Study ID Numbers: MED-2016-23735
First Posted: March 23, 2016    Key Record Dates
Last Update Posted: August 10, 2022
Last Verified: August 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Minnesota:
diet
carbohydrate
protein
glucose
type 2 diabetes mellitus
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases