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High Protein Diet vs High Carbohydrate Diet for Type 2 Diabetes
N/A
Recruiting
Led By Frankie B Stentz, PhD
Research Sponsored by University of Tennessee Health Science Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
BMI > 30 kg/m2 to 55kg/m2
Age range 20 yrs to 50 yrs
Timeline
Screening 3 weeks
Treatment Varies
Follow Up each subject will be monitored for 6 months while they are on the hp or hc diet
Awards & highlights
Study Summary
This trial is testing whether a high protein diet can help people with Type 2 diabetes go into remission and improve their metabolism.
Who is the study for?
This trial is for men and women aged 20-50 with newly diagnosed Type 2 Diabetes, a BMI of 30-55 kg/m2, and specific blood glucose levels. It's not for those with kidney issues, on certain meds, long-term diabetes (>2 years), or high blood pressure among other exclusions.Check my eligibility
What is being tested?
The study compares the effects of a High Protein (HP) diet versus a High Carbohydrate (HC) diet over six months to see if they can induce remission in Type 2 Diabetes by providing food and menus to ensure compliance.See study design
What are the potential side effects?
While not explicitly listed, potential side effects may include changes in digestion due to dietary adjustments, fluctuations in energy levels, and possible nutrient deficiencies depending on individual health conditions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My BMI is between 30 and 55.
Select...
I am between 20 and 50 years old.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ each subject will be monitored for 6 months while they are on the hp or hc diet for remission of type 2 diabetes
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~each subject will be monitored for 6 months while they are on the hp or hc diet for remission of type 2 diabetes
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Diabetes Mellitus, Non-Insulin-Dependent
Secondary outcome measures
Cardiovascular Risk Factors (CVR)
Inflammation markers such as cytokines
Metabolom Markers
+1 moreTrial Design
2Treatment groups
Active Control
Group I: High protein (HP) weight loss dietActive Control1 Intervention
A weight loss high protein (HP) (30% Kcal protein, 40% Kcal carbohydrate (CHO) and 30% Kcal fat) diet will be given to the subjects on that arm of study to pick up weekly for 6 months.
Group II: High carbohydrate (HC) weight loss dietActive Control1 Intervention
A weight loss high carbohydrate (HC) (15% Kcal protein, 55% Kcal CHO and 30% Kcal fat) diet will be given to the subjects on that arm of study to pick up weekly for 6 months.
Intervention with the HC diet will be 6 months. If subjects have not had remission of Type 2 Diabetes by the end of the 6 months, they will be referred to an endocrinologist for pharmaceutical treatment
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Who is running the clinical trial?
University of Tennessee Health Science CenterLead Sponsor
48 Previous Clinical Trials
25,004 Total Patients Enrolled
University of TennesseeLead Sponsor
189 Previous Clinical Trials
141,929 Total Patients Enrolled
Frankie B Stentz, PhDPrincipal InvestigatorUniversity of Tennessee
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am taking medication that affects my cholesterol or blood sugar levels.I have had cancer or been treated for it in the last 5 years.My HbA1c level is above 10% and I need to see a specialist for treatment.My BMI is between 30 and 55.I am between 20 and 50 years old.Your body mass index (BMI) is between 30 and 55.Your triglycerides are higher than 400 mg/dl or your LDL cholesterol is higher than 160 mg/dl.I have liver disease or abnormal liver tests.My thyroid is not working properly, as shown by my TSH levels.You have too much protein in your urine or high levels of creatinine in your blood.I have had type 2 diabetes for more than 2 years.I have lost more than 10% of my body weight in the last 6 months.You have a history of drinking alcohol excessively.You weigh more than 350 pounds and cannot fit on the DXA machine.You are a smoker.I am currently using a CPAP machine for my sleep apnea.Your blood sugar levels are too high after fasting or after drinking a sugary solution.Your blood pressure is higher than 145/100 mm Hg.Your HbA1c level is too high, between 6.5% and 10%.I have gone through menopause due to surgery or earlier than expected.
Research Study Groups:
This trial has the following groups:- Group 1: High protein (HP) weight loss diet
- Group 2: High carbohydrate (HC) weight loss diet
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.
Type 2 Diabetes Patient Testimony for trial: Trial Name: NCT03832725 — N/A
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What type of patients are ideal candidates to participate in this clinical investigation?
"The criteria for this study necessitates that participants possess newly diagnosed type 2 diabetes, be between 20 and 50 years of age, and there are 100 slots available."
Answered by AI
How many participating volunteers comprise this research project?
"Absolutely. According to clinicaltrials.gov, this investigation is actively seeking participants as of now. The trial was first advertised on March 1st 2018 and its most recent update occurred on February 5th 2019; the study hopes to source 100 individuals from a single site."
Answered by AI
Does the age of eighty or above disqualify participants from joining this trial?
"This research is recruiting volunteers who are between 20 and 50 years old."
Answered by AI
Are there any available slots for enrollment in this clinical trial?
"Yes, this clinical trial is still open for enrollment. According to the data available on clinicialtrials.gov, it was initially posted in March 2018 and recently updated in February 2019."
Answered by AI
Who else is applying?
What state do they live in?
Tennessee
What site did they apply to?
University of Tennessee Health Science Center
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0
1
Why did patients apply to this trial?
I want to lose weight. I’m tried of being fat & ugly … I have never been this big and I want to live to see my 5 grandchildren grow up…plz help!!!
PatientReceived no prior treatments
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