An interventional study of Metformin treatment and Placebo treatment in Impaired Glucose Tolerance and Diabetes Mellitus, Type 2, sponsored by Kristian Karstoft. Completed at 1 site in Denmark. Open to participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-11-09.
Sponsored by Kristian Karstoft · Not applicable, Interventional, and Basic science
Among 23 studies testing metformin in Glucose Intolerance — 2 open to participants now, 3 under way, none of them phase 3. Metformin · Glucose Intolerance.
Among the 23 studies testing metformin in Glucose Intolerance, this one is the 14th largest by enrollment of the 22 interventional ones that give a count, is one of 4 that started in 2017, is one of 8 with no phase, and was the 15th registered.
793 studies on the registry are indexed under Glucose Intolerance; 115 are open to participants now.
Browse Glucose Intolerance studies →2 of the 23 studies testing metformin in Glucose Intolerance are open now, in 1 country. Recruiting first, the newest first:
The University of Texas Health Science Center at San Antonio · Sites in United States
Ages 18+
The University of Texas Health Science Center at San Antonio · Sites in United States
Ages 18–65 · Healthy volunteers
By country, each count listing its studies:
Metformin: first FDA approval 1995 (GLUCOPHAGE), first EMA approval 2003. What it is approved for, and how studies give it, is on its page →
Of the 70 Glucose Intolerance studies recruiting now, 14 (20%) set no upper age limit and 51 (73%) stop at 75 or younger; 10 take children under 18; 33 take healthy volunteers.
This study: 18 Years to 70 Years · all sexes · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
23 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 3 · Phase 2 7 · Phase 3 4 · Phase 4 3
First in 1996; this study’s year is marked. 4 started in 2017.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 34 is below the median of 56 across 661 interventional studies indexed under Glucose Intolerance.
Median enrollment 45 across the 22 interventional studies. Of the 16 that completed or were terminated, 7 (44%) have results posted.
This tab as a report to print or save as PDF → With an account.
1 of 23 have an industry lead sponsor. The 10 most frequent:
Kristian Karstoft is the lead sponsor of 4 studies on the registry; none are open to participants now.
Kristian Karstoft has 2 studies filed under Glucose Intolerance — fewer than ten, so there is no comparison to draw.
2 of the studies testing metformin in Glucose Intolerance that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT02969798The University of Texas Health Science Center at San AntonioPre-diabetes in Subject With Impaired Fasting Glucose (IFG) and Impaired Glucose Tolerance (IGT) | 2027-02-28 |
| NCT06446531The University of Texas Health Science Center at San AntonioPrevention of Progression of Prediabetes, Obesity and CV Risk | 2027-07 |
Add all 2 to your calendar (.ics) → With an account.
Among the 23 studies testing metformin in Glucose Intolerance, from their registry updates:
This tab as a report to print or save as PDF → With an account.
Physical activity is a first line treatment for patients with type 2 diabetes (T2D), however, the vast majority of patients with T2D do not achieve satisfying glycemic control with physical activity alone, which is why pharmacological treatment with metformin is most often initiated.
It is known that metformin and exercise both activates 5' adenosine monophosphate-activated protein kinase (AMPK) in skeletal muscle and liver, and the activation of AMPK results in many different metabolic effects, including improvements in glycemic control. Because of this similarity in mechanism of action, an interaction between metformin and exercise is plausible, but knowledge in the area is sparse. Thus, the aim of this study is to assess the effects of training with and without concomitant metformin treatment, in order to investigate whether an interaction between the two occur.
Subjects with impaired glucose tolerance will all undergo 12 weeks of training but will be randomized (1:1) to concomitant metformin/placebo treatment in a double-blinded way. Experimental days will be performed before randomisation (before initiation of metformin/placebo treatment), before initiation of the training period and after the training period.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: Metformin treatment · Behavioral: Physical training
Drug: Placebo treatment · Behavioral: Physical training
Daily treatment with metformin tablets for 101 days according to the following scheme: Day 1-4: Metformin tablet 500 mg x 2 Day 5-8: Metformin tablet 1000 + 500 mg Day 9-101: Metformin tablet 1000 mg x 2
Daily treatment with placebo tablets for 101 days according to the following scheme: Day 1-4: Placebo tablet 500 mg x 2 Day 5-8: Placebo tablet 1000 + 500 mg Day 9-101: Placebo tablet 1000 mg x 2
Twelve weeks of supervised physical training (4 times per week, 45 min per session, mean intensity at 70% of maximal oxygen consumption rate)
Change in postprandial glycemic control as assessed by mean blood glucose concentration during a 4 hour mixed-meal tolerance test
Time frame: Day 0 (before randomisation), 17 (after initiation of metformin/placebo treatment), 101 (after 12 weeks of training)
Change in free-living glycemic control
Blood HbA1c levels
Time frame: Day 0 (before randomisation), 17 (after initiation of metformin/placebo treatment), 101 (after 12 weeks of training)
Change in endogenous glucose production as assessed by rate of infused glucose tracer appearance in blood
Time frame: Day 0 (before randomisation), 17 (after initiation of metformin/placebo treatment), 101 (after 12 weeks of training)
Change in exogenous glucose uptake as assessed by rate of ingested glucose tracer appearance in blood
Time frame: Day 0 (before randomisation), 17 (after initiation of metformin/placebo treatment), 101 (after 12 weeks of training)
Change in peripheral glucose uptake as assessed by rate of glucose disappearance from blood
Time frame: Day 0 (before randomisation), 17 (after initiation of metformin/placebo treatment), 101 (after 12 weeks of training)
Change in maximal oxygen consumption
Maximal oxygen uptake during an incremental bicycle test
Time frame: Day 17 (after initiation of metformin/placebo treatment), 101 (after 12 weeks of training)
Change in body weight
Body weight measured by standard procedures
Time frame: Day 17 (after initiation of metformin/placebo treatment), 101 (after 12 weeks of training)
Change in lean body mass
Lean body mass evaluated via Dual energy x-ray absorptiometry (Dxa)
Time frame: Day 17 (after initiation of metformin/placebo treatment), 101 (after 12 weeks of training)
Change in total fat mass
Total body fat mass evaluated via Dual energy x-ray absorptiometry (Dxa)
Time frame: Day 17 (after initiation of metformin/placebo treatment), 101 (after 12 weeks of training)
Change in visceral fat mass
Visceral fat mass evaluated via magnetic resonance imaging (MRI) scans
Time frame: Day 17 (after initiation of metformin/placebo treatment), 101 (after 12 weeks of training)
Change in AMPK activity in skeletal muscle
AMPK activity measured via western blotting and activity assays
Time frame: Day 17 (after initiation of metformin/placebo treatment), 101 (after 12 weeks of training)
Change in skeletal muscle oxidative stress
Muscle mitochondrial oxidative stress measured via respirometry in muscle biopsies
Time frame: Day 17 (after initiation of metformin/placebo treatment), 101 (after 12 weeks of training)
Change in systemic oxidative stress
Systemic oxidative stress measured via RNA/DNA oxidation products in urine
Time frame: Day 0 (before randomisation), 17 (after initiation of metformin/placebo treatment), 101 (after 12 weeks of training)
Maximal mitochondrial respiration
Maximal mitochondrial respiration measured via respirometry in muscle biopsies
Time frame: Day 17 (after initiation of metformin/placebo treatment), 101 (after 12 weeks of training)
Training heart rate
Heart rate will be measured continuously during all training sessions
Time frame: Average heart rate during all training sessions (through study completion, [Day 101])
Training rate of perceived exertion
Rate of perceived exertion measured via a Borg scale (range 6-20 where higher values indicate higher rate of perceived exertion) will be assessed for each training session
Time frame: Average rate of perceived exertion of all training sessions (through study completion, [Day 101])
Plan to share: Undecided
Ran from Oct 2017 to primary completion in Oct 2018, 11 months.
Of 254 non-industry interventional studies with no phase under Glucose Intolerance, half reached primary completion within 26 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 44. This study's 11 months is below that.
Counting every sponsor, half of 286 studies reached it within 26 months; a quarter within 10 and three quarters within 44.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Nov 2018. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Metformin
Kristian Karstoft