Lifestyle Intervention for Type 2 Diabetes

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Arizona State University, Phoenix, AZType 2 Diabetes+2 MoreLifestyle Intervention - Behavioral
Eligibility
10 - 99
All Sexes
What conditions do you have?
Select

Study Summary

This trial will test a lifestyle intervention to see if it can reduce type 2 diabetes risk factors and increase quality of life among high-risk Latino families.

Eligible Conditions
  • Type 2 Diabetes
  • Obesity
  • Childhood Obesity

Treatment Effectiveness

Study Objectives

1 Primary · 6 Secondary · Reporting Duration: 16 weeks

16 weeks
Dietary behaviors
Glucose Tolerance
Physical Activity
Bone and Bones
Total body composition-fat
Total body composition-muscle
Weight Specific Quality of Life (QoL)

Trial Safety

Side Effects for

Metformin
35%Diarrhea
22%headache/migraine
22%common cold/respiratory tract infection
16%nausea and/or vomiting
15%flu
13%dysmenorrhea/cramps
11%stomach/abdominal pain or discomfort
9%musculoskeletal
5%dizziness
5%hair loss
5%vaginal infection
5%dental issues
4%fatigue
4%flatulence
2%bladder infection
This histogram enumerates side effects from a completed 2008 Phase 2 trial (NCT00151411) in the Metformin ARM group. Side effects include: Diarrhea with 35%, headache/migraine with 22%, common cold/respiratory tract infection with 22%, nausea and/or vomiting with 16%, flu with 15%.

Trial Design

2 Treatment Groups

Comparison control
1 of 2
Lifestyle Intervention
1 of 2

Active Control

Experimental Treatment

132 Total Participants · 2 Treatment Groups

Primary Treatment: Lifestyle Intervention · No Placebo Group · N/A

Lifestyle Intervention
Behavioral
Experimental Group · 1 Intervention: Lifestyle Intervention · Intervention Types: Behavioral
Comparison controlNoIntervention Group · 1 Intervention: Comparison control · Intervention Types:
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Lifestyle Intervention
2001
Completed Phase 2
~8880

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 16 weeks

Who is running the clinical trial?

Arizona State UniversityLead Sponsor
248 Previous Clinical Trials
89,093 Total Patients Enrolled
Phoenix Children's HospitalOTHER
68 Previous Clinical Trials
5,011,890 Total Patients Enrolled
St. Vincent de Paul Medical and Dental ClinicOTHER
2 Previous Clinical Trials
152 Total Patients Enrolled
Valley of the Sun YMCA, ArizonaOTHER
1 Previous Clinical Trials
117 Total Patients Enrolled
University of WashingtonOTHER
1,610 Previous Clinical Trials
1,572,945 Total Patients Enrolled
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,182 Previous Clinical Trials
4,088,765 Total Patients Enrolled

Eligibility Criteria

Age 10 - 99 · All Participants · 6 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You identify yourself as American Indian.
You identify as Latino based on your self-report.

Frequently Asked Questions

How many individuals have enrolled in this clinical experiment?

"Absolutely. Clinicaltrials.gov confirms that this clinical experiment, which was originally written on December 12th 2021, is actively searching for participants. 132 individuals are being accepted at a single site." - Anonymous Online Contributor

Unverified Answer

Do I fit the requirements to enter this scientific evaluation?

"The criteria for admittance into this clinical trial is pediatric obesity, and an age range of 10-99 years old. An approximate 132 individuals are being accepted as participants in the study." - Anonymous Online Contributor

Unverified Answer

Is this research available to the public at present?

"Affirmative. The information available on clinicaltrials.gov verifies that this scientific trial, established December 12th 2021, is actively engaging participants in recruitment efforts. A total of 132 volunteers are necessary from just one medical facility." - Anonymous Online Contributor

Unverified Answer

Is the study open to geriatric patients?

"This clinical trial allows for participation between the ages of 10 and 99, as per its inclusion criteria." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.