IGF-1 Levels
| Group | Value (ng/ml) | Spread |
|---|---|---|
| Self-Directed | 73.2 | 19.9 |
| Coach Directed Behavioral Weight Loss | 73.6 | 20.9 |
| Metformin | 71.2 | 21.4 |
Trial · Interventional
CompletedPhase 2Results postedRegistry dataShort name SPIRIT
This trial does not test a peptide that PepBank tracks.
United States
1 trial · 1 completed · 1 with posted results
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
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
Outcomes the sponsor listed as primary.
IGF-1 Levels
Time frame · 6 months
Insulin-like growth factor (IGF)-1 levels (ng/ml) at 6 months.
IGF-1 Levels
Time frame · 12 months
IGF-1 at 12 months
IGF-1 to IGFBP3 Level Ratio (Molar Ratio)
Time frame · 6 months
IGF-1 level to IGFBP3 level ratio (molar ratio) at 6 months.
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
| Group | Value (ng/ml) | Spread |
|---|---|---|
| Self-Directed | 73.2 | 19.9 |
| Coach Directed Behavioral Weight Loss | 73.6 | 20.9 |
| Metformin | 71.2 | 21.4 |
| Group | Value (ng/ml) | Spread |
|---|---|---|
| Self-Directed | 73.4 | 20.7 |
| Coach Directed Behavioral Weight Loss | 76.6 | 25.7 |
| Metformin | 76.2 | 25.7 |
| Group | Value (ratio) | Spread |
|---|---|---|
| Self-Directed | 0.18 | 0.047 |
| Coach Directed Behavioral Weight Loss | 0.18 | 0.065 |
| Metformin | 0.17 | 0.046 |
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| Group | Value |
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| Group | Deaths | Serious events | Other 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 loss | 0 / 40 | 5 / 40 | 10 / 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 goals | 0 / 39 | 5 / 39 | 3 / 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 / 42 | 12 / 42 | 6 / 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
Studies that cite this trial.
No study cites this trial.
References listed at the registry that are not in PepBank. They link to PubMed.
Who could join, as posted.
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