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Hormone Therapy

Low-Carb, High-Unsaturated Fat Diet for Obesity

N/A

Waitlist Available

Led By Dr Tracey Lynn McLaughlin

Research Sponsored by Stanford University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

BMI 30-35

No active major organ diseases

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

Study Summary

This trial is testing the hypothesis that in obese, insulin-resistant individuals, a diet lower in carbohydrate and higher in mono/polyunsaturated fats will lead to greater weight loss and reduction in CHD risk factors, as compared to a standard hypocaloric diet. Additionally, the trial will compare diabetics treated with insulin secretagogues (drugs that increase insulin secretion) to diabetics treated with insulin sensitizers (drugs that decrease insulin concentrations) to see if there are differences in weight loss, change in insulin resistance, blood pressure, lipid and lipoproteins, markers of endothelial function, daylong insulin and glucose

Who is the study for?

This trial is for adults aged 35-65 with obesity (BMI between 30 and 35) who are not diabetic, do not have major organ diseases or active malignancies, chronic inflammatory conditions, eating disorders, psychiatric illnesses, or anemia. Participants must be either insulin resistant or sensitive.Check my eligibility

What is being tested?

The study is testing how different diets and diabetes medications affect weight loss and the risk of heart disease in obese individuals. One part compares two low-calorie diets differing in carbs and fats; another compares medication effects on insulin levels. Outcomes like weight change and cardiovascular markers will be measured.See study design

What are the potential side effects?

Potential side effects may include changes in blood sugar levels due to diet alteration or diabetes medications used during the trial. These could lead to symptoms such as fatigue, hunger fluctuations, dizziness if glucose drops too low, or discomfort from dietary adjustments.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My BMI is between 30 and 35.

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I do not have any active major organ diseases.

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I am between 35 and 65 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Weight loss

Secondary outcome measures

Blood pressure changes

Endothelial function changes

Insulin resistance changes

+1 more

0 / 3Eligibility criteria met

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Who is running the clinical trial?

Stanford UniversityLead Sponsor

2,386 Previous Clinical Trials

17,333,458 Total Patients Enrolled

69 Trials studying Obesity

269,686 Patients Enrolled for Obesity

Dr Tracey Lynn McLaughlinPrincipal InvestigatorStanford University

Media Library

Diabetes treatment with insulin secretagogues (Hormone Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT00186459 — N/A

Obesity Clinical Trial 2023: Diabetes treatment with insulin secretagogues Highlights & Side Effects. Trial Name: NCT00186459 — N/A

Diabetes treatment with insulin secretagogues (Hormone Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT00186459 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are participants of thirty years and older being sought after for this examination?

"This clinical study requires that patients are between 18 and 65 years old. However, there exists 202 trials specifically for minors, while seniors can participate in 596 different studies."

Answered by AI

What are the qualifications needed for participation in this clinical experiment?

"For this trial, 550 individuals aged 18-65 are needed who have obesity. Furthermore, the participants must also satisfy specific conditions including BMI between 30 and 35, age between 35 and 65, nondiabetic by fasting plasma glucose concentration, no active major organ diseases, insulin resistant or insulin sensitive."

Answered by AI

Is this research endeavor taking on new participants at the present time?

"As per the data on clinicaltrials.gov, this experiment is not actively searching for participants at present. The study was first uploaded to the database in October 2000 and last modified 13 years ago in March 2013. While this trial is inactive, 956 other trials are currently recruiting patients worldwide."

Answered by AI