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Behavioural Intervention

Metformin for Polycystic Ovarian Syndrome

Phase < 1
Waitlist Available
Led By Jennifer L Phy, DO
Research Sponsored by Texas Tech University Health Sciences Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
PCOS
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 8 weeks
Awards & highlights

Study Summary

This trial looked at the effects of a low starch diet on weight and metabolism in women with PCOS, compared to the traditional treatment of metformin, diet, and exercise.

Eligible Conditions
  • Polycystic Ovarian Syndrome
  • Malnutrition
  • Metabolism
  • Diet Modification

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
You have polycystic ovary syndrome (PCOS).

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~8 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 8 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
BMI
Weight
Secondary outcome measures
cholesterol
fasting glucose
fasting insulin
+3 more

Side effects data

From 2015 Phase 4 trial • 156 Patients • NCT02002221
13%
Nasopharyngitis
10%
Hyperhidrosis
9%
Hunger
9%
Tremor
8%
Asthenia
6%
Hypoglycaemia
1%
Squamous cell carcinoma of the tongue
1%
Femoral neck fracture
100%
80%
60%
40%
20%
0%
Study treatment Arm
Vildagliptin (LAF237)
Placebo

Trial Design

3Treatment groups
Experimental Treatment
Group I: Traditional TreatmentExperimental Treatment1 Intervention
Participant receives recommendations for caloric intake, exercise and prescription for metformin if indicated
Group II: One-On-One Low Starch Dietary InstructionExperimental Treatment1 Intervention
Participant receives One-On-One Low Starch Dietary Instruction from Study Collaborator
Group III: Low Starch Dietary Instruction by VideoExperimental Treatment1 Intervention
Participant receives Low Starch Dietary Instruction by Video Link
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Metformin
2006
Completed Phase 4
~2430

Find a Location

Who is running the clinical trial?

Texas Tech University Health Sciences CenterLead Sponsor
103 Previous Clinical Trials
10,573 Total Patients Enrolled
Jennifer L Phy, DOPrincipal InvestigatorTexas Tech University Health Sciences Center
1 Previous Clinical Trials
60 Total Patients Enrolled

Frequently Asked Questions

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

Could you share any prior studies that have explored the use of Metformin?

"As of now, 170 clinical trials for Metformin exist with 43 being in the final stage. Although most are situated in Pittsburgh, Pennsylvania there is a total of 1903 sites conducting these studies."

Answered by AI

Which individuals would be appropriate candidates for this trial?

"This clinical trial will welcome 71 individuals who are suffering from nutritional disturbances and must be within 18-45 years of age. Noteworthy, the participants should have a Body Mass Index (BMI) between 25 to 45, access to an electronic device with internet connection, female gender in that same age group, and Polycystic Ovary Syndrome (PCOS)."

Answered by AI

Are there any opportunities for candidates to enroll in this experiment?

"This medical trial, originally published on August 29th 2018 and most recently updated on October 19th 2022, is not presently recruiting. Despite this, the same source indicates that there are 249 other clinical trials taking part in patient recruitment."

Answered by AI

How many case studies are currently being recruited for this research?

"This clinical trial is no longer open to recruitment; the posting was first published on August 29th, 2018 and last modified on October 19th 2022. If you're looking for alternative medical studies, there are currently 79 trials recruiting patients with nutrition disorders and 170 Metformin-related investigations seeking participants."

Answered by AI

Is the age requirement for enrollment in this experiment greater than twenty years?

"The parameters for patient eligibility dictate that the minimum age of participation is 18 and that those over 45 cannot be included in this study."

Answered by AI

What is the aim of this experiment?

"This 8 week trial is designed to measure BMI with secondary goals of assessing waist-to-hip ratio, fasting insulin levels and cholesterol concentrations."

Answered by AI

In what cases is Metformin typically prescribed?

"Metformin is a medication used to control various manifestations of diabetes, including type 1 diabetes mellitus, diabetic ketoacidosis, and polycystic ovary syndrome. It can also be prescribed for off-label exercise related treatments."

Answered by AI
~11 spots leftby Mar 2025