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NCT02717078 · ClinicalTrials.gov registry record · NA
The LoBAG Diet and Type 2 Diabetes Mellitus
A NA study, sponsored by University of Minnesota.
- Completed
- Registry status
- NA
- Development phase
- 48
- Enrollment target
NCT02717078 is a NA study that has completed, run by University of Minnesota. The registered enrollment target is 48 participants.
The verdict
NCT02717078, a NA study, has completed, sponsored by University of Minnesota.
- COMPLETED
- Registry status
- NA
- Development phase
- 48 participants
- Enrollment target
Study 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.
Interventions
- OTHER Diet Therapy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 48 participants |
| Start Date | 2017-06-19 |
| Est. Completion | 2023-02-14 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02717078
The ClinicalTrials.gov registry entry for NCT02717078 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 48 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Minnesota, which has 966 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Diet Therapy is the first listed.
NCT02717078 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02717078 about?
NCT02717078 is a clinical study titled "The LoBAG Diet and Type 2 Diabetes Mellitus". 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...
What is the current status of trial NCT02717078?
This trial is currently completed. It is a NA study. The enrollment target is 48 participants. The study started on 2017-06-19. Estimated completion is 2023-02-14.
What interventions are being tested in trial NCT02717078?
The interventions under investigation include: Diet Therapy (OTHER).
Who is sponsoring clinical trial NCT02717078?
This trial is sponsored by University of Minnesota, which has 966 total clinical trials registered on ClinicalTrials.gov.
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