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Diet Therapy for Type 2 Diabetes

N/A
Waitlist Available
Led By Anne Bantle, MD
Research Sponsored by University of Minnesota
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 12
Awards & highlights

Study Summary

This trial will compare the LoBAG diet to a control diet in 38 participants with DM2 over 12 weeks, measuring HgbA1c, weight, fasting plasma glucose, fasting serum insulin, postprandial plasma glucose and serum insulin, serum fructosamine, fasting serum lipids, stool samples for gut microbiome analysis, and quality of life surveys. Compliance outcomes will include urine nitrogen to creatinine ratio, survey data, three-day food diaries, and unannounced 24-hour diet recalls.

Eligible Conditions
  • Type 2 Diabetes

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 12
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 12 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in hemoglobin A1c from baseline to week 12
Secondary outcome measures
24-hour diet recall
Change in fasting plasma glucose from baseline to week 12
Change in fasting serum insulin from baseline to week 12
+8 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: LoBAG DietExperimental Treatment1 Intervention
Assignment to consume the LoBAG diet (30% carbohydrate, 30% protein, 40% fat; carbohydrates that are low in starch emphasized) for 12 weeks.
Group II: Control DietActive Control1 Intervention
Assignment to consume the control diet (50% carbohydrate, 15% protein, 35% fat) for 12 weeks.

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Who is running the clinical trial?

University of MinnesotaLead Sponsor
1,391 Previous Clinical Trials
1,553,068 Total Patients Enrolled
Anne Bantle, MDPrincipal InvestigatorUniversity of Minnesota
~10 spots leftby Jun 2025
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