DiabetesNCT00339313
Food Intake and Appetite in the Children of Mothers With Diabetes
An observational study of Diabetes, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at 1 site in United States.
Trial summary
This protocol is for study of the effect of inhibition of parasympathetic outflow on insulin secretion and glucose metabolism. Insulin secretion will be measured during infusions of escalating doses of atropine. Other clinical parameters of parasympathetic inhibition by atropine will also be assessed. Read more about this study
- Who is it for?
- Ages 7 to 10 years
- Conditions the study is for
- Diabetes
- How many people
- 240 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Jan 2000to 24 Jun 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
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 7 to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Group 1: Offspring of mothers with diabetes during pregnancy.
- Maternal diagnosis of type 2 diabetes (by WHO criteria after a 75g OGTT or on clinical grounds with at least one random plasma glucose greater than 200mg/dl) before or during the index pregnancy.
- Group 2: Offspring of mothers with diabetes diagnosed following pregnancy.
- Maternal diagnosis of type 2 diabetes (by WHO criteria after a 75g OGTT or on clinical grounds with at least one random plasma glucose greater than 200 mg/dl) after the index pregnancy.
- It is important to also ensure that these mothers did not have any major disturbance in glucose tolerance during the index pregnancy and a record of normal glucose tolerance after the index pregnancy; therefore they will only be included if there are also:
- Adequate records of glucose testing during the index pregnancy and these records are not in keeping with a diagnosis of gestational diabetes (by either WHO criteria if a 75g oral glucose tolerance test has been carried out).
- At least one non-diabetic OGTT after the index pregnancy.
Who cannot join
- History of weight loss for child (greater than 2kg over last 6 months).
- Presence of other major illnesses which might interfere with appetite or food intake in mother or child.
- Child not living with mother.
Trial locations and contacts
1 site in 1 country.
About this study
This protocol is for study of the effect of inhibition of parasympathetic outflow on insulin secretion and glucose metabolism. Insulin secretion will be measured during infusions of escalating doses of atropine. Other clinical parameters of parasympathetic inhibition by atropine will also be assessed.
Read the detailed description
Children of mothers who had diabetes during pregnancy are at an increased risk of diabetes and obesity in later life, effects partly mediated by the early environment experienced by the offspring of diabetic mothers in utero. In this protocol, we address why intra-uterine exposure to maternal diabetes might lead to later childhood obesity. Previous studies of children of diabetic mothers have not detected any alteration in energy expenditure, either as resting metabolic rate or physical activity. We will now examine whether they are at an increased risk of obesity due to differences in food intake. We will assess composition of the diet, patterns of eating, taste preference and physiological responses to a mixed meal. No previous work in human subjects has addressed these issues.
- Conditions
- Diabetes
- Keywords
- Obesity, Etiology, Macronutrient Selection, Taste Preference, Mixed Meal Test
- Medical subject headings
- Diabetes Mellitus, Obesity
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2006 (estimated)
- Study start12 Jan 2000
- Study completion24 Jun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for DiabetesStudies of the same condition, open and under way.
- More trials run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)The sponsor's other registered studies.
- 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
- Observational
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00339313
- Sponsor's protocol ID
- 999900005
- Other IDs
- OH00-DK-N005
- Status last verified
- 24 Jun 2011
- First submitted
- 19 Jun 2006
- Last updated
- 2 Jul 2017
- Results posted
- No
Publications
Pettitt DJ, Baird HR, Aleck KA, Bennett PH, Knowler WC. Excessive obesity in offspring of Pima Indian women with diabetes during pregnancy. N Engl J Med. 1983 Feb 3;308(5):242-5. doi: 10.1056/NEJM198302033080502.
PubMed 6848933Silverman BL, Landsberg L, Metzger BE. Fetal hyperinsulinism in offspring of diabetic mothers. Association with the subsequent development of childhood obesity. Ann N Y Acad Sci. 1993 Oct 29;699:36-45. doi: 10.1111/j.1749-6632.1993.tb18835.x. No abstract available.
PubMed 8267335Pettitt DJ, Aleck KA, Baird HR, Carraher MJ, Bennett PH, Knowler WC. Congenital susceptibility to NIDDM. Role of intrauterine environment. Diabetes. 1988 May;37(5):622-8. doi: 10.2337/diab.37.5.622.
PubMed 3360218
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Food Intake and Appetite in the Children of Mothers With Diabetes
- ClinicalTrials.gov ID
- NCT00339313
- Acronym / sponsor ID
- 999900005
- Conditions
- Diabetes
- Keywords
- Obesity, Etiology, Macronutrient Selection, Taste Preference, Mixed Meal Test
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)US National Institutes of Health
- Study start
- 12 Jan 2000
- Study completion
- 24 Jun 2011
- First posted
- 21 Jun 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This protocol is for study of the effect of inhibition of parasympathetic outflow on insulin secretion and glucose metabolism. Insulin secretion will be measured during infusions of escalating doses of atropine. Other clinical parameters of parasympathetic inhibition by atropine will also be assessed.
Detailed description
Children of mothers who had diabetes during pregnancy are at an increased risk of diabetes and obesity in later life, effects partly mediated by the early environment experienced by the offspring of diabetic mothers in utero. In this protocol, we address why intra-uterine exposure to maternal diabetes might lead to later childhood obesity. Previous studies of children of diabetic mothers have not detected any alteration in energy expenditure, either as resting metabolic rate or physical activity. We will now examine whether they are at an increased risk of obesity due to differences in food intake. We will assess composition of the diet, patterns of eating, taste preference and physiological responses to a mixed meal. No previous work in human subjects has addressed these issues.
Study design
Who may qualify
- Ages
- 7 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Group 1: Offspring of mothers with diabetes during pregnancy.
- Maternal diagnosis of type 2 diabetes (by WHO criteria after a 75g OGTT or on clinical grounds with at least one random plasma glucose greater than 200mg/dl) before or during the index pregnancy.
- Group 2: Offspring of mothers with diabetes diagnosed following pregnancy.
- Maternal diagnosis of type 2 diabetes (by WHO criteria after a 75g OGTT or on clinical grounds with at least one random plasma glucose greater than 200 mg/dl) after the index pregnancy.
- It is important to also ensure that these mothers did not have any major disturbance in glucose tolerance during the index pregnancy and a record of normal glucose tolerance after the index pregnancy; therefore they will only be included if there are also:
Key exclusion criteria (3 listed)
- History of weight loss for child (greater than 2kg over last 6 months).
- Presence of other major illnesses which might interfere with appetite or food intake in mother or child.
- Child not living with mother.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2017.
- Background: PubMed 6848933Pettitt DJ, Baird HR, Aleck KA, Bennett PH, Knowler WC. Excessive obesity in offspring of Pima Indian women with diabetes during pregnancy. N Engl J Med. 1983 Feb 3;308(5):242-5. doi: 10.1056/NEJM198302033080502.
- Background: PubMed 8267335Silverman BL, Landsberg L, Metzger BE. Fetal hyperinsulinism in offspring of diabetic mothers. Association with the subsequent development of childhood obesity. Ann N Y Acad Sci. 1993 Oct 29;699:36-45. doi: 10.1111/j.1749-6632.1993.tb18835.x. No abstract available.
- Background: PubMed 3360218Pettitt DJ, Aleck KA, Baird HR, Carraher MJ, Bennett PH, Knowler WC. Congenital susceptibility to NIDDM. Role of intrauterine environment. Diabetes. 1988 May;37(5):622-8. doi: 10.2337/diab.37.5.622.
Related trials for Diabetes
Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Effects of Lean Pork Loin Intake on Protein Homeostasis and Glucose Regulation in Prediabetic Adults
Hyperglycaemia (Non Diabetic), Prediabetes
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) 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 7 inclusion and 3 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 2 Jul 2017. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00339313, which also lists 3 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 2 Jul 2017.