Clinical trial · Interventional
Survivorship Promotion In Reducing IGF-1 Trial
Trial of Behavioral Weight Loss and Metformin Treatment to Lower Insulin Growth Factor in Cancer Survivors
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (11)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Colon Cancer | Malignant Colon Neoplasm | CURATED_EXACT | 0.92 |
| Endometrial Cancer | Malignant Endometrial Neoplasm | CURATED_BROADER | 0.80 |
| Kidney Cancer | Malignant Kidney Neoplasm | CURATED_EXACT | 0.92 |
| Liver Cancer | Malignant Liver Neoplasm | CURATED_EXACT | 0.92 |
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
| Melanoma of Skin | Cutaneous Melanoma | ALIAS | 0.90 |
| Other Solid Malignant Tumors | — | UNRESOLVED |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Coach Directed Behavioral Weight Loss | Behavioral | — | UNRESOLVED |
| Metformin | Drug | Metformin | ALIAS |
| Self-control weight loss | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- ACTIVE_COMPARATOR
- label
- Self-Directed
- description
- In this group, the study staff will meet with you once at the beginning of the study to give you written information about weight management.
- interventionNames
- Behavioral: Self-control weight loss
- type
- EXPERIMENTAL
- label
- Coach Directed Behavioral Weight Loss
- description
- The Remote Lifestyle Coaching intervention is based on the Call Center Directed intervention to help you loss weight
- interventionNames
- Behavioral: Coach Directed Behavioral Weight Loss
- type
- EXPERIMENTAL
- label
- Metformin
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Women and men ages 18 or older * Have been previously diagnosed with a malignant solid tumor, completed their required surgical, and/or chemotherapy and/or radiation curative intent therapy at least three months prior to enrollment, and have an anticipated treatment-free life span of 12 months or longer. Chemoprophylaxis with tamoxifen or aromatase inhibitors for breast cancer in women and anti- Luteinizing hormone-releasing hormone (LHRH) therapy for prostate cancer in men will be permitted. * Have a BMI of 25 kg/m\^2 or greater and weight \<=400 lbs. * Willingness to accept randomization to each of the three arms * Willingness to change diet, physical activity, and weight * Regular access to computer with a reliable Internet connection * Ability to send and receive emails * Ability to complete online forms * Access to phone * Willingness to provide written informed consent Exclusion Criteria: * Women who are breastfeeding, pregnant, or planning pregnancy within the next year * Medication-treated diabetes * Fasting blood glucose \>=200 mg/dL, or fasting blood glucose \>=126 and \<200 mg/dL and HbA1C \>=7% * Current or prior regular use of metformin within the past 3 months * Uncontrolled concurrent medical condition likely to limit compliance with the study interventions * Received any chemotherapy (unless anti-hormonal therapy) and/or radiation three months or less prior to the proposed intervention date * Have a prior history of lactic acidosis by self-report * Prior or planned bariatric surgery * Have significant renal disease or dysfunction defined as Estimated glomerular filtration rate (eGFR)\<45 * Have significant hepatic dysfunction \[Aspartate aminotransferase (AST)/Alanine transaminase (ALT) ≥ 2 x upper limit of normal (ULN) or reported liver disease\] * Self-reported average consumption of \> 14 alcoholic drink per week * Currently enrolled or planned to enroll in weight loss program * Hemoglobin \<9 g/dl * Platelet count \<100 * White blood cell count (WBC) \<2.5 * Plans to relocate from the area within one years * Use of prescription weight loss medication(s) (e.g., lorcaserin, topiramate/phentermine, phentermine, liraglutide, and bupropion/naltrexone), including off label use of drugs for weight loss or over-the-counter weigh loss medications such as Orlistat within the past 6 months.
References
Publications (5)
- DERIVEDTilves C, Yeh HC, Maruthur N, Juraschek SP, Miller E, White K, Appel LJ, Mueller NT. Increases in Circulating and Fecal Butyrate are Associated With Reduced Blood Pressure and Hypertension: Results From the SPIRIT Trial. J Am Heart Assoc. 2022 Jul 5;11(13):e024763. doi: 10.1161/JAHA.121.024763. Epub 2022 Jun 22. PMID 35730613
- DERIVEDTilves C, Yeh HC, Maruthur N, Juraschek SP, Miller ER, Appel LJ, Mueller NT. A behavioral weight-loss intervention, but not metformin, decreases a marker of gut barrier permeability: results from the SPIRIT randomized trial. Int J Obes (Lond). 2022 Mar;46(3):655-660. doi: 10.1038/s41366-021-01039-2. Epub 2022 Jan 6. PMID 34987204
- DERIVEDHu JR, Yeh HC, Mueller NT, Appel LJ, Miller ER 3rd, Maruthur NM, Jerome GJ, Chang AR, Gelber AC, Juraschek SP. Effects of a Behavioral Weight Loss Intervention and Metformin Treatment on Serum Urate: Results from a Randomized Clinical Trial. Nutrients. 2021 Jul 31;13(8):2673. doi: 10.3390/nu13082673. PMID 34444833
- DERIVEDMueller NT, Differding MK, Zhang M, Maruthur NM, Juraschek SP, Miller ER 3rd, Appel LJ, Yeh HC. Metformin Affects Gut Microbiome Composition and Function and Circulating Short-Chain Fatty Acids: A Randomized Trial. Diabetes Care. 2021 Jul;44(7):1462-1471. doi: 10.2337/dc20-2257. Epub 2021 May 18. PMID 34006565
- DERIVEDJuraschek SP, Plante TB, Charleston J, Miller ER, Yeh HC, Appel LJ, Jerome GJ, Gayles D, Durkin N, White K, Dalcin A, Hermosilla M. Use of online recruitment strategies in a randomized trial of cancer survivors. Clin Trials. 2018 Apr;15(2):130-138. doi: 10.1177/1740774517745829. Epub 2018 Jan 24. PMID 29361843