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Behavioral Intervention
Low-Carb Breakfast for Type 2 Diabetes
Phase 1 & 2
Recruiting
Research Sponsored by University of Michigan
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
18-80 years old
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 0-4 months
Awards & highlights
Study Summary
This trial will explore if a low-carb breakfast program could help 120 adults with type 2 diabetes manage their condition better.
Who is the study for?
Adults aged 18-80 with type 2 diabetes, specifically those who have an HbA1c level of 8% or higher and are willing to follow a very low-carbohydrate breakfast program. Participants must understand English, be able to consent and follow instructions, and regularly check their blood glucose levels. Excluded are those already on similar diets, involved in conflicting studies, with certain medical conditions like heart or kidney failure, untreated mental health issues, or specific dietary restrictions like veganism.Check my eligibility
What is being tested?
The study is testing the impact of a very low-carbohydrate breakfast-focused diet over four months on adults with type 2 diabetes. It's online-based and will look at how well participants accept this diet plan (acceptability), can stick to it (feasibility), and its preliminary effectiveness by measuring changes in blood sugar control (HbA1c), medication needs, weight fluctuation, blood pressure variation, and cholesterol levels.See study design
What are the potential side effects?
While not explicitly stated for this dietary intervention trial focused on breakfast consumption patterns for individuals with type 2 diabetes; potential side effects may include digestive discomfort due to significant dietary changes such as constipation or indigestion.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 18 and 80 years old.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 0-4 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~0-4 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
HbA1c change
Secondary outcome measures
Change in Inflammation based on high sensitivity C-reactive protein (hsCRP)
Change in glycemic variability
Change in high-density lipoproteins (HDL)
+5 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Very low-carbohydrate breakfastExperimental Treatment1 Intervention
Materials will encourage eating a very low-carbohydrate breakfast (or first meal of the day), with no more than about 5-10 non-fiber (net) grams of carbohydrates each.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Breakfast
2015
Completed Phase 3
~310
Find a Location
Who is running the clinical trial?
University of MichiganLead Sponsor
1,798 Previous Clinical Trials
6,378,018 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are currently on a diet that contains very few carbohydrates or you often skip breakfast.You follow a vegan diet.I rely on someone else to prepare my meals.I have cancer, heart failure, or kidney failure.I have trouble chewing or swallowing.I have type 1 diabetes or signs suggesting it, like low C-peptide or a past of diabetic ketoacidosis.I am between 18 and 80 years old.Your thyroid levels are not within the normal range.You have a history of alcoholism.Your HbA1c level is 8% or higher.You have a mental health condition that has not been treated.I have had weight loss surgery in the past.
Research Study Groups:
This trial has the following groups:- Group 1: Very low-carbohydrate breakfast
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What type of participant is most suitable for this experiment?
"To meet the criteria for this trial, potential participants should have type 2 diabetes and be aged between 18 and 80. The enrollment cap is set at 120 patients."
Answered by AI
How many participants are included in this research project?
"Affirmative, the information hosted on clinicaltrials.gov demonstrates that this study is currently searching for participants. This research trial was first posted on August 2nd 2023 and recently updated on the same day; it requires 120 subjects to be enrolled from one medical centre."
Answered by AI
Is enrollment open to individuals below the age of 55 for this experiment?
"This study is open to all adults aged 18 and over, with 44 trials available specifically for those under the legal age of consent and 746 studies designed for individuals older than 65."
Answered by AI
Are there any openings available for those wishing to join this clinical trial?
"Yes, according to clinicaltrials.gov this study is actively recruiting participants as of August 2nd 2023. The trial was initially posted on the same day and has since been modified once. A total of 120 patients are needed at a single medical facility for successful completion of this project."
Answered by AI
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