Trials / Completed
CompletedNCT02431676
Survivorship Promotion In Reducing IGF-1 Trial
Trial of Behavioral Weight Loss and Metformin Treatment to Lower Insulin Growth Factor in Cancer Survivors
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 121 (actual)
- Sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This is a prospective, single-center randomized trial with three arms, and an allocation ratio of 1:1:1. The study design is an efficacy study to evaluate the effect of metformin and coach-directed behavioral weight loss versus self-directed weight loss on insulin-like growth factor (IGF)-1 and IGF-1 to THE IGFBP-III ratio blood levels after 6 and 12 months of intervention. The coach-directed Behavioral Weight Loss arm is a web-based remote delivery and communication system that promotes healthy behavioral changes. The Metformin arm is a pharmaceutical intervention of oral metformin. This is a secondary prevention study for men and women who have survived solid malignant tumors
Conditions
- Breast Cancer
- Prostate Cancer
- Lung Cancer
- Colon Cancer
- Melanoma of Skin
- Endometrial Cancer
- Liver Cancer
- Pancreatic Cancer
- Rectal Cancer
- Kidney Cancer
- Other Solid Malignant Tumors
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Metformin | Participants will receive metformin, an oral medication for type 2 diabetes.Participants randomized to the metformin intervention will receive metformin up to 2,000 mg per day.Dosing can be flexible, two or three times per day with meals as tolerated for 12 months. |
| BEHAVIORAL | Coach Directed Behavioral Weight Loss | Behavioral-based telephonic coaching with web-based support to promote healthy lifestyle and weight loss in overweight and obese adults.The goal of this intervention is to achieve at least 5% weight loss in the first six months of the intervention and maintain these improvements through month twelve by meeting dietary and exercise goals |
| BEHAVIORAL | Self-control weight loss |
Timeline
- Start date
- 2015-05-01
- Primary completion
- 2018-12-01
- Completion
- 2018-12-01
- First posted
- 2015-05-01
- Last updated
- 2024-08-28
- Results posted
- 2020-09-16
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT02431676. Inclusion in this directory is not an endorsement.