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Trial · Interventional

CompletedPhase 2Results postedRegistry data

Survivorship Promotion In Reducing IGF-1 Trial

Short name SPIRIT

NCTNCT02431676 (opens ClinicalTrials.gov in a new tab)Other idJ14148Other idIRB00035653

This trial does not test a peptide that PepBank tracks.

  • Measures IGF-1 (mecasermin), does not give it. It appears in an outcome measure.

Overview

Status
Completed
Phase
Phase 2
Enrollment
121 participants (actual)
Sponsor
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins · Other
Design
Randomized · Single masking
Countries
1 country

United States

Start
May 2015
Primary completion
Dec 2018
Completion
Dec 2018
First posted
1 May 2015 (estimated)
Last update posted
28 Aug 2024
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

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20152016201720182019
  1. Ph 2

    SPIRIT

    NCT02431676

    May 2015 to Dec 2018

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown 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

Interventions

  • MetforminDrug
  • Coach Directed Behavioral Weight LossBehavioral
  • Self-control weight lossBehavioral

Arms3

  • Active comparator

    Self-Directed

    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.

  • Experimental

    Coach Directed Behavioral Weight Loss

    The Remote Lifestyle Coaching intervention is based on the Call Center Directed intervention to help you loss weight

  • Experimental

    Metformin

    This group will be given the study drug called Metformin. Metformin comes in tablet form that you take with meals

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. IGF-1 Levels

    Time frame · 6 months

    Registry description

    Insulin-like growth factor (IGF)-1 levels (ng/ml) at 6 months.

Secondary outcomes(2)
  1. IGF-1 Levels

    Time frame · 12 months

    Registry description

    IGF-1 at 12 months

  2. IGF-1 to IGFBP3 Level Ratio (Molar Ratio)

    Time frame · 6 months

    Registry description

    IGF-1 level to IGFBP3 level ratio (molar ratio) at 6 months.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMean· 6 months

IGF-1 Levels

GroupValue (ng/ml)Spread
Self-Directed73.219.9
Coach Directed Behavioral Weight Loss73.620.9
Metformin71.221.4
Secondary and other outcome results(7)
Secondary outcomeMean· 12 months

IGF-1 Levels

GroupValue (ng/ml)Spread
Self-Directed73.420.7
Coach Directed Behavioral Weight Loss76.625.7
Metformin76.225.7
Secondary outcomeMean· 6 months

IGF-1 to IGFBP3 Level Ratio (Molar Ratio)

GroupValue (ratio)Spread
Self-Directed0.180.047
Coach Directed Behavioral Weight Loss0.180.065
Metformin0.170.046
Other pre specified outcome· 6 and 12 months

Weight Measured by Scale(Kg)

GroupValue
Other pre specified outcome· 6 and 12 months

Body Mass Index Measured by Scale and Tap(kg/m2)

GroupValue
Other pre specified outcome· 6 and 12 months

EuroQol Score Assessed by Questionnaire

GroupValue
Other pre specified outcome· 6 and 12 months

Dietary Intake Assessed by Questionnaire

GroupValue
Other pre specified outcome· 6 and 12 months

Physical Activity Amount Assessed by Questionnaire

GroupValue

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Self-DirectedIn this group, the study staff will meet with you once at the beginning of the study to give you written information about weight management. Self-control weight loss0 / 405 / 4010 / 40
Coach Directed Behavioral Weight LossThe Remote Lifestyle Coaching intervention is based on the Call Center Directed intervention to help you loss weight 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 goals0 / 395 / 393 / 39
MetforminThis group will be given the study drug called Metformin. Metformin comes in tablet form that you take with meals 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.0 / 4212 / 426 / 42

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Other registry references

References listed at the registry that are not in PepBank. They link to PubMed.

  • 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

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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.

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