Low Milk SupplyPhase 1/2MALMSNCT02179788
Metformin to Augment Low Milk Supply (MALMS) Study
A Phase 1/2 study testing Metformin in people with Low Milk Supply and Pre-diabetes, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.
Trial summary
Most new mothers in the United States will start off breastfeeding. For some mothers, despite following best practices, they are not able to meet their breastfeeding goals due to unexplained low milk supply. At the same time, nearly 1 in 4 new mothers are pre-diabetic (elevated blood sugar, but not yet diabetic). Read more about this study
- Who is it for?
- Ages 20 years and older, women only
- Conditions the study is for
- Low Milk Supply, Pre-diabetes, Insulin Resistance
- What is being tested?
- Metformin
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2014to Jul 2016
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Stage 1 Criteria (for participation in baseline measurement phase):
- identified with low milk supply by a Cincinnati-area IBCLC
- mother denies obvious cause of low milk supply such as pituitary disorder, breast surgery, severe lack of breast emptying (< 4 times per day), or failure to show any signs of lactogenesis
- mother at least 20 years of age
- infant is between 1 week and 2 calendar months old
- mother gave birth to a single, healthy, term (>37 weeks gestation) infant
Show all 31Show fewer
- mother free of breast and nipple infections
- mother lives within study catchment area
- mother has not been diagnosed with Type 1 or Type 2 Diabetes Mellitus
- mother willing to sustain consistent use of herbal galactogogues (such as fenugreek) during follow up measurements (2-4 weeks) as was consumed during the baseline measurements
- mother not currently taking a prescription medication that may affect the hormones of lactation and not planning to initiate any such drug for at least the next 2-4 weeks.
- mother has established pediatric care for the infant
- Stage 2 maternal inclusion criteria (among those who meet Stage 1 criteria, to continue with enrollment into randomized controlled trial, goal, N=30 with replacement for non-completers to at least two weeks):
- successful completion of baseline measurements (involving 24-hour test weighing of milk output and undergoing baseline measurements at the clinical research center, including providing fasting blood samples)
- body mass index is >19.0 kg/m2 (i.e., not underweight)
- evidence of likely insulin resistance, based on at least one of the following: mean fasting plasma glucose between 95.0 - 125.0 g/dL, inclusive; abdominal obesity; history of polycystic ovary syndrome; or history of gestational diabetes
- estimated glomerular filtration rate > 60 mL/min
- liver function in normal range (AST <= 37 U/L, ALT < 87 U/L, and total bilirubin <= 1.1 mg/dL
- willingness to continue trying to lactate for the next 2-4 weeks
- health history does not reveal illness/treatments for which metformin is contraindicated
- participant is not currently being treated with metformin
- Eligibility criteria for enrollment into abundant milk supply comparison group (goal, N=30, will be compared in baseline measurements).
- exclusively feeding mother's own milk to infant, and presenting to Cincinnati area IBCLC with breastfeeding question or problem unrelated to milk supply
- mother at least 20 years of age
- infant is between 1 week and 2 calendar months old
- mother gave birth to a single, term infant
- mother free of breast and nipple infections
- mother lives within study catchment area
- mother has not been diagnosed with Type 1 or Type 2 Diabetes Mellitus
- mother willing to sustain consistent use of herbal galactogogues (such as fenugreek) during baseline measurements
- mother willing to avoid prescription medication that may affect the hormones of lactation
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229-3039
About this study
Official title: Metformin to Augment Low Milk Supply in Pre-diabetic Mothers, a Phase I/II Randomized Clinical Trial
Most new mothers in the United States will start off breastfeeding. For some mothers, despite following best practices, they are not able to meet their breastfeeding goals due to unexplained low milk supply. At the same time, nearly 1 in 4 new mothers are pre-diabetic (elevated blood sugar, but not yet diabetic). My progression of research suggests that the same metabolic factors causing pre-diabetes may also be causing low milk supply. Metformin is a widely prescribed drug to treat high blood sugar. This study is a preliminary, small scale randomized trial designed to test for a trend in the hypothesis that metformin is safe and potentially effective in treating low milk supply in insulin resistant and pre-diabetic mothers.
Read the detailed description
Through a progression of research, the PI has developed the central hypothesis that waning insulin secretion in the context of insulin resistance is an important cause of low milk supply. The specific aim of the research described in this protocol is to enact a small-scale randomized placebo-controlled trial (RCT) that will inform a future larger double-masked RCT of adjuvant metformin treatment versus placebo for early postpartum low milk supply in women with evidence of insulin resistance based on the presence of at least one of the following: elevated fasting glucose (FPG, defined as >95 g/dL), history of polycystic ovary syndrome, history of gestational diabetes, or current abdominal obesity. The pilot study is designed to demonstrate feasibility, obtain variance estimates, and test for an trend in the following primary hypothesis: 1) Among eligible women with low milk supply, those randomly assigned to 4 weeks of metformin treatment will experience a greater increase in milk output as compared to the placebo group. The RCT will be preceded by a"process testing phase" in which recruitment and data collection logistics will be confirmed by enacting the study protocol, except without any drug assignment. Upon completion of the process testing phase, the protocol will be amended according to insights gained. Once the revised protocol received IRB approval, the RCT phase will begin. During this phase, mothers meeting Stage 1 eligibility criteria will undergo baseline measurements of cardio-metabolic health and breast milk output. Among mothers meeting stage 2 eligibility criteria, including FPG >95 g/dL, N=30 will be randomly assigned to metformin or placebo using a 2:1 allocation, with replacement of non-completers. All low milk supply participants will receive the standard guidance for increasing milk supply with breast pumping. We will test the following secondary hypotheses: 2) Mammary epithelial cell transcriptomes within the metformin group, but not placebo, will exhibit significantly greater modulation of insulin-stimulated genes between baseline and post treatment. Milk fat globules are a rich source of mammary epithelial cell mRNA. We will isolate milk fat RNA at baseline and post treatment and randomly select a subset for RNA-sequencing. 3) Fasting plasma glucose >95 g/dL will correctly identify low milk supply cases with >75% sensitivity; and <95 g/dL will correctly identify abundant milk supply (comparator group) with >90% specificity. Fasting plasma glucose (FPG) in women with abundant milk supply will be derived from 30 consecutively consenting breastfeeding medicine patients who meet all RCT eligibility criteria except low milk supply (i.e., diagnoses related to infant feeding at the breast such as poor latch, but with abundant milk output). We will combine all available baseline FPG data to determine the sensitivity and specificity of FPG >95 g/dL as biomarker of low milk supply caused by maternal metabolic impairment. 4) Metformin treatment will be safe and adequately tolerated by the lactating mother and her breastfeeding infant.
- Being tested
- Standard care, Metformin, Placebo
- Keywords
- lactation, breastfeeding, human milk, insulin, metformin, prediabetes, pre-diabetes, insulin resistance
- Medical subject headings
- Glucose Intolerance, Insulin Resistance, Breast Feeding, Prediabetic State
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard careBehavioural
Also called Breast expression
Mothers will be instructed to thoroughly empty their breasts at least 8 times per 24 hours by breastfeeding, followed by breast expression with a combination of hand -expression and the use of a hospital-grade electric breast pump (provided by study).
MetforminDrug
Also called Glucophage
The metformin arm will be consuming Glucophage XR (metformin hydrochloride extended release, 750 or 500 mg, encapsulated in #00 opaque capsules for 4 weeks according to the following schedule:
- Days 1-7, take one 750 mg capsule with evening meal (750 mg/day)
- Days 8-14, take three 500 mg capsule with evening meal (1500 mg/day)
- Days 14-28 (or through completion of post-intervention data collection), take four 500 mg capsules with evening meal (2000 mg/day)
Actual increase in dose may occur more slowly if standard titration schedule is not well tolerated. Adjustments to schedule will be made in consultation with the adult medicine study co-investigator.
The trial duration is 28 days (with a +/- 3 day cushion)
PlaceboDrug
Also called methylcellulose
The placebo arm will be consuming methylcellulose USP Powder encapsulated in #00 opaque capsules (supplied by PCCA, Houston TX) for 4 weeks according to the following schedule:
- Days 1-7, take 1 capsule with evening meal
- Days 8-14, take 3 capsules with evening meal
- Days 14-28 (or through completion of post-intervention data collection), take four capsules with evening meal
Actual increase in dose may occur more slowly if standard titration schedule is not well tolerated. Adjustments to schedule will be made in consultation with the adult medicine study co-investigator.
| Study group | Role | What they receive |
|---|---|---|
| Standard care plus metformin | Experimental | 67% of stage 2 eligible mothers will be randomly allocated to this arm. Mothers will be instructed to thoroughly empty their breasts at least 8 times per day and to take the assigned study drug. Receives: Behavioral: Standard care; Drug: Metformin |
| Standard Care plus placebo | Placebo comparator | 33% of Stage 2 eligible mothers will be randomly allocated to this arm. Mothers will be instructed to thoroughly empty their breasts at least 8 times per day (Standard Care) and to take the assigned study drug. The placebo arm will be consuming methylcellulose USP Powder encapsulated in #00 opaque capsules (supplied by PCCA, Houston TX) for 4 weeks according to the following schedule:
* Days 1-7, take 1 capsule with evening meal
* Days 8-14, take 3 capsules with evening meal
* Days 14-28 (or through completion of post-intervention data collection), take four capsules with evening meal
Actual increase in dose may occur more slowly if standard titration schedule is not well tolerated. Adjustments to schedule will be made in consultation with the adult medicine study co-investigator. Receives: Behavioral: Standard care; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak Change in Milk Output
Maximal change in maternal breast milk production (g/24 hours) between baseline and 4 weeks post-intervention in a model adjusted for baseline milk volume, maternal day postpartum of randomization, and baseline fasting plasma glucose.
Measured: baseline and 4 weeks post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2014 (estimated)
- Study startJun 2014
- Primary completionJul 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Low Milk SupplyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Medical Center, Cincinnati
- Sponsor type
- University, hospital or other
- Collaborators
- University of Cincinnati
- Responsible party
- Sponsor
- Investigators
- Laurie A Nommsen-Rivers, PhD, Principal investigator, Children's Hospital Medical Center, Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02179788
- Sponsor's protocol ID
- Cin_002_MALMS
- Other IDs
- IRB protocol number 2012-2333
- Acronym
- MALMS
- Status last verified
- Sep 2016
- First submitted
- 30 Jun 2014
- Last updated
- 19 Oct 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Nommsen-Rivers LA, Chantry CJ, Peerson JM, Cohen RJ, Dewey KG. Delayed onset of lactogenesis among first-time mothers is related to maternal obesity and factors associated with ineffective breastfeeding. Am J Clin Nutr. 2010 Sep;92(3):574-84. doi: 10.3945/ajcn.2010.29192. Epub 2010 Jun 23.
PubMed 20573792Nommsen-Rivers LA, Dolan LM, Huang B. Timing of stage II lactogenesis is predicted by antenatal metabolic health in a cohort of primiparas. Breastfeed Med. 2012 Feb;7(1):43-9. doi: 10.1089/bfm.2011.0007. Epub 2011 Apr 27.
PubMed 21524193Lemay DG, Ballard OA, Hughes MA, Morrow AL, Horseman ND, Nommsen-Rivers LA. RNA sequencing of the human milk fat layer transcriptome reveals distinct gene expression profiles at three stages of lactation. PLoS One. 2013 Jul 5;8(7):e67531. doi: 10.1371/journal.pone.0067531. Print 2013.
PubMed 23861770Wagner EA, Chantry CJ, Dewey KG, Nommsen-Rivers LA. Breastfeeding concerns at 3 and 7 days postpartum and feeding status at 2 months. Pediatrics. 2013 Oct;132(4):e865-75. doi: 10.1542/peds.2013-0724. Epub 2013 Sep 23.
PubMed 24062375Nommsen-Rivers L, Thompson A, Riddle S, Ward L, Wagner E, King E. Feasibility and Acceptability of Metformin to Augment Low Milk Supply: A Pilot Randomized Controlled Trial. J Hum Lact. 2019 May;35(2):261-271. doi: 10.1177/0890334418819465. Epub 2019 Jan 10.
PubMed 30629889
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metformin to Augment Low Milk Supply in Pre-diabetic Mothers, a Phase I/II Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT02179788
- Acronym / sponsor ID
- MALMS / Cin_002_MALMS
- Keywords
- lactation, breastfeeding, human milk, insulin, metformin, prediabetes, pre-diabetes, insulin resistance
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Children's Hospital Medical Center, CincinnatiUniversity, hospital or other
- Collaborators
- University of Cincinnati
- Study start
- Jun 2014
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 2 Jul 2014 (estimated)
- Results
- Posted 19 Oct 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Most new mothers in the United States will start off breastfeeding. For some mothers, despite following best practices, they are not able to meet their breastfeeding goals due to unexplained low milk supply. At the same time, nearly 1 in 4 new mothers are pre-diabetic (elevated blood sugar, but not yet diabetic). My progression of research suggests that the same metabolic factors causing pre-diabetes may also be causing low milk supply. Metformin is a widely prescribed drug to treat high blood sugar. This study is a preliminary, small scale randomized trial designed to test for a trend in the hypothesis that metformin is safe and potentially effective in treating low milk supply in insulin resistant and pre-diabetic mothers.
Detailed description
Through a progression of research, the PI has developed the central hypothesis that waning insulin secretion in the context of insulin resistance is an important cause of low milk supply. The specific aim of the research described in this protocol is to enact a small-scale randomized placebo-controlled trial (RCT) that will inform a future larger double-masked RCT of adjuvant metformin treatment versus placebo for early postpartum low milk supply in women with evidence of insulin resistance based on the presence of at least one of the following: elevated fasting glucose (FPG, defined as >95 g/dL), history of polycystic ovary syndrome, history of gestational diabetes, or current abdominal obesity. The pilot study is designed to demonstrate feasibility, obtain variance estimates, and test for an trend in the following primary hypothesis: 1) Among eligible women with low milk supply, those randomly assigned to 4 weeks of metformin treatment will experience a greater increase in milk output as compared to the placebo group. The RCT will be preceded by a"process testing phase" in which recruitment and data collection logistics will be confirmed by enacting the study protocol, except without any drug assignment. Upon completion of the process testing phase, the protocol will be amended according to insights gained. Once the revised protocol received IRB approval, the RCT phase will begin. During this phase, mothers meeting Stage 1 eligibility criteria will undergo baseline measurements of cardio-metabolic health and breast milk output. Among mothers meeting stage 2 eligibility criteria, including FPG >95 g/dL, N=30 will be randomly assigned to metformin or placebo using a 2:1 allocation, with replacement of non-completers. All low milk supply participants will receive the standard guidance for increasing milk supply with breast pumping. We will test the following secondary hypotheses: 2) Mammary epithelial cell transcriptomes within the metformin group, but not placebo, will exhibit significantly greater modulation of insulin-stimulated genes between baseline and post treatment. Milk fat globules are a rich source of mammary epithelial cell mRNA. We will isolate milk fat RNA at baseline and post treatment and randomly select a subset for RNA-sequencing. 3) Fasting plasma glucose >95 g/dL will correctly identify low milk supply cases with >75% sensitivity; and <95 g/dL will correctly identify abundant milk supply (comparator group) with >90% specificity. Fasting plasma glucose (FPG) in women with abundant milk supply will be derived from 30 consecutively consenting breastfeeding medicine patients who meet all RCT eligibility criteria except low milk supply (i.e., diagnoses related to infant feeding at the breast such as poor latch, but with abundant milk output). We will combine all available baseline FPG data to determine the sensitivity and specificity of FPG >95 g/dL as biomarker of low milk supply caused by maternal metabolic impairment. 4) Metformin treatment will be safe and adequately tolerated by the lactating mother and her breastfeeding infant.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard care plus metformin | Experimental | Behavioral: Standard care, Drug: Metformin67% of stage 2 eligible mothers will be randomly allocated to this arm. Mothers will be instructed to thoroughly empty their breasts at least 8 times per day and to take the assigned study drug. |
| Standard Care plus placebo | Placebo comparator | Behavioral: Standard care, Drug: Placebo33% of Stage 2 eligible mothers will be randomly allocated to this arm. Mothers will be instructed to thoroughly empty their breasts at least 8 times per day (Standard Care) and to take the assigned study drug. The placebo arm will be consuming methylcellulose USP Powder encapsulated in #00 opaque capsules (supplied by PCCA, Houston TX) for 4 weeks according to the following schedule: * Days 1-7, take 1 capsule with evening meal * Days 8-14, take 3 capsules with evening meal * Days 14-28 (or through completion of post-intervention data collection), take four capsules with evening meal Actual increase in dose may occur more slowly if standard titration schedule is not well tolerated. Adjustments to schedule will be made in consultation with the adult medicine study co-investigator. |
Who may qualify
- Ages
- 20 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (31 listed)
- identified with low milk supply by a Cincinnati-area IBCLC
- mother denies obvious cause of low milk supply such as pituitary disorder, breast surgery, severe lack of breast emptying (< 4 times per day), or failure to show any signs of lactogenesis
- mother at least 20 years of age
- infant is between 1 week and 2 calendar months old
- mother gave birth to a single, healthy, term (>37 weeks gestation) infant
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard careAlso: Breast expressionMothers will be instructed to thoroughly empty their breasts at least 8 times per 24 hours by breastfeeding, followed by breast expression with a combination of hand -expression and the use of a hospital-grade electric breast pump (provided by study). | Behavioural | Standard Care plus placebo, Standard care plus metformin |
| MetforminAlso: GlucophageThe metformin arm will be consuming Glucophage XR (metformin hydrochloride extended release, 750 or 500 mg, encapsulated in #00 opaque capsules for 4 weeks according to the following schedule: * Days 1-7, take one 750 mg capsule with evening meal (750 mg/day) * Days 8-14, take three 500 mg capsule with evening meal (1500 mg/day) * Days 14-28 (or through completion of post-intervention data collection), take four 500 mg capsules with evening meal (2000 mg/day) Actual increase in dose may occur more slowly if standard titration schedule is not well tolerated. Adjustments to schedule will be made in consultation with the adult medicine study co-investigator. The trial duration is 28 days (with a +/- 3 day cushion) | Drug | Standard care plus metformin |
| PlaceboAlso: methylcelluloseThe placebo arm will be consuming methylcellulose USP Powder encapsulated in #00 opaque capsules (supplied by PCCA, Houston TX) for 4 weeks according to the following schedule: * Days 1-7, take 1 capsule with evening meal * Days 8-14, take 3 capsules with evening meal * Days 14-28 (or through completion of post-intervention data collection), take four capsules with evening meal Actual increase in dose may occur more slowly if standard titration schedule is not well tolerated. Adjustments to schedule will be made in consultation with the adult medicine study co-investigator. | Drug | Standard Care plus placebo |
Primary outcome
Peak Change in Milk Output
Time frame: baseline and 4 weeks post-intervention
Maximal change in maternal breast milk production (g/24 hours) between baseline and 4 weeks post-intervention in a model adjusted for baseline milk volume, maternal day postpartum of randomization, and baseline fasting plasma glucose.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 20573792Nommsen-Rivers LA, Chantry CJ, Peerson JM, Cohen RJ, Dewey KG. Delayed onset of lactogenesis among first-time mothers is related to maternal obesity and factors associated with ineffective breastfeeding. Am J Clin Nutr. 2010 Sep;92(3):574-84. doi: 10.3945/ajcn.2010.29192. Epub 2010 Jun 23.
- Background: PubMed 21524193Nommsen-Rivers LA, Dolan LM, Huang B. Timing of stage II lactogenesis is predicted by antenatal metabolic health in a cohort of primiparas. Breastfeed Med. 2012 Feb;7(1):43-9. doi: 10.1089/bfm.2011.0007. Epub 2011 Apr 27.
- Background: PubMed 23861770Lemay DG, Ballard OA, Hughes MA, Morrow AL, Horseman ND, Nommsen-Rivers LA. RNA sequencing of the human milk fat layer transcriptome reveals distinct gene expression profiles at three stages of lactation. PLoS One. 2013 Jul 5;8(7):e67531. doi: 10.1371/journal.pone.0067531. Print 2013.
- Background: PubMed 24062375Wagner EA, Chantry CJ, Dewey KG, Nommsen-Rivers LA. Breastfeeding concerns at 3 and 7 days postpartum and feeding status at 2 months. Pediatrics. 2013 Oct;132(4):e865-75. doi: 10.1542/peds.2013-0724. Epub 2013 Sep 23.
- Derived from this study: PubMed 30629889Nommsen-Rivers L, Thompson A, Riddle S, Ward L, Wagner E, King E. Feasibility and Acceptability of Metformin to Augment Low Milk Supply: A Pilot Randomized Controlled Trial. J Hum Lact. 2019 May;35(2):261-271. doi: 10.1177/0890334418819465. Epub 2019 Jan 10.
- United States Office of Women's Health Breastfeeding Support and Resources websiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Laurie A Nommsen-Rivers, PhD principal investigator
Children's Hospital Medical Center, Cincinnati
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Metformin in people with Low Milk Supply and Pre-diabetes, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 31 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Oct 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peak Change in Milk Output (time frame: baseline and 4 weeks post-intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02179788, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2020.